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The Future of Fertility

In 2016, two Japanese reproductive biologists, Katsuhiko Hayashi and Mitinori Saitou, made an announcement in the journal Nature that read like a science-fiction novel. The researchers had taken skin cells from the tip of a mouse’s tail, reprogrammed them into stem cells, and then turned those stem cells into egg cells. The eggs, once fertilized, were transferred to the uteruses of female mice, who gave birth to ten pups; some of the pups went on to have babies of their own. Gametes are the cells, such as eggs and sperm, that are essential for sexual reproduction. With their experiment, Hayashi and Saitou provided the first proof that what’s known as in-vitro gametogenesis, or I.V.G.—the production of gametes outside the body, beginning with nonreproductive cells—was possible in mammals. The mice that had descended from the lab-made egg cells were described as “grossly normal.”

The Japanese experiment may change the science of human reproduction. The first successful in-vitro fertilization, in 1978, made it possible to conceive an embryo outside the body. Today, approximately two per cent of all babies in the United States are conceived in a lab, through I.V.F.—last year, analysts valued the global I.V.F. market at more than twenty-three billion dollars. Egg cells have become commodities that are harvested, bought, donated, and preserved. But egg cells, some of the most complex cells in the body, and large enough to be visible to the naked eye, are difficult to obtain; as a woman ages, their number and quality decline. “If ripe human eggs could be derived from a person’s skin cells, it would avoid most of the cost, almost all of the discomfort, and all of the risk of IVF,” the Stanford bioethicist Henry Greely wrote in his 2016 book, “The End of Sex and the Future of Human Reproduction,” addressing new techniques to make stem cells which had won the Nobel Prize in 2012. He predicted that in the next twenty to forty years sex will no longer be the method by which most people make babies (“among humans with good health coverage,” he qualified).

A hundred years ago, many Americans died in their mid-fifties. Today, we can expect to live into our seventies and eighties. In the U.S., as in many other countries, women give birth for the first time at older ages than they did several decades ago, but the age at which women lose their fertility has not budged: by forty-five, a person’s chances of having a pregnancy without assisted reproductive technology are exceedingly low.

Biologists have theories, none of them conclusive, about why women have such a sharp decline in fertility at midlife, and why ovaries age at least twice as fast as the other organs in the body. Deena Emera, an evolutionary geneticist and the author of a forthcoming book about evolution and the female body, told me that the vast majority of female mammals, including chimpanzees, maintain the ability to get pregnant for most of their lives. Elephants, which can live up to seventy years, can conceive and give birth into their sixth decade. Human females share their long post-reproductive life span with only a few other mammals, mostly species of toothed whales. We are connected in this strange and frustrating reality with narwhals, belugas, and orcas. There’s much debate, if not a definitive answer, about why.

In the U.S., according to census data, the number of births to women under the age of twenty-five has dropped significantly since 1990; an increase in births to women over thirty-five has not compensated for the decline. The United Nations has estimated that in 2019 nearly half the global population lived in countries with below-replacement fertility rates, which the U.N. defines as fewer than 2.1 births per woman. (In our country, population growth is also driven by immigration.) While the over-all growth in human population is not anticipated to plateau until the mid-twenty-eighties, economists say that aging populations in countries with fewer children can affect, among other things, the continued growth of economies, the provision of health care, and the funding of pension systems. Although there are also social and environmental benefits to a decrease in the global population, many countries are recognizing that they can no longer take a passive approach to fertility issues.

In recent years, the science of extending female reproductive longevity has seen a new flurry of interest, and biotech companies are attempting to begin clinical trials of a number of therapies, including new I.V.F. techniques and pharmaceuticals. (The research has earned philanthropic attention as well—Hayashi’s and Saitou’s labs are funded in part by Open Philanthropy, a foundation set up by the Facebook co-founder Dustin Moskovitz and his wife, the former journalist Cari Tuna.) But the ability to make egg cells without human ovaries would apply not only to people who are designated female at birth. This March, Hayashi, who is not currently trying to make a human egg, had another announcement: his lab had repeated the I.V.G. process in mice, but this time it had produced fertilized embryos whose egg cells had been developed using stem cells from male mice—“mice with two dads,” as the headline in Nature put it. Futurists have speculated about broader possibilities, such as an embryo formed with the DNA of four people instead of two, or even a so-called “unibaby,” the result of a person reproducing with herself. In a less hypothetical realm, in-vitro gametogenesis may have applications in livestock breeding, and might one day play a role in preserving endangered species—a group of scientists, including Hayashi, have been attempting to use the method to generate eggs from the northern white rhinoceros, a species of which only two females remain.

In some circles, I.V.G. is already seen as the future of reproductive science. Bianka Seres, a co-founder of a startup called Conception Biosciences, which is trying to make egg cells from stem cells, told me that I.V.G.—along with a related, though more far-fetched, prospect, artificial wombs—was a prominent theme at the American Society for Reproductive Medicine’s annual conference in 2021, hinting at a time when gestation could happen outside the human body. “It wasn’t ‘Oh, maybe this will happen,’ ” she said. “It was very factual: when this happens, this is how we’re going to use it.” She and her colleagues believe that one day dozens of egg cells might be generated from a simple biopsy or blood sample, perhaps even one taken from someone who is biologically male. Conception might not be the company that figures out I.V.G., but the prevailing sense is that it’s only a matter of time before someone does.

In late January, I visited the headquarters of Conception, in Berkeley. The company was founded in 2018, and has since raised almost forty million dollars in venture capital in pursuit of in-vitro gametogenesis. The staff was temporarily based in a single-story co-working space near Aquatic Park, and things had gotten crowded. Conception’s C.E.O., a thirty-one-year-old entrepreneur named Matt Krisiloff, was working from an armchair wedged between two desks. Krisiloff first tweeted about his interest in I.V.G. in 2017. At the time, he was the director of a nonprofit wing of Y Combinator, the startup incubator, established to fund technological research “for the benefit of the world,” as the company put it. Sam Altman, who was then running Y Combinator, told me that he and Krisiloff were both interested in what he called “hard-tech companies that invest a long time in developing a difficult technology first and then don’t bring a first product to market for many, many years.” Krisiloff had helped out in the early months of OpenAI, which went on to invent ChatGPT, Dall-E , and the transcription service Whisper, an experience he has cited as formative in learning how to set up a research-oriented company with an ambitious end goal.

Krisiloff has close-cropped hair and a gap-toothed smile, and on the day of my visit he was dressed in jeans, a black crew-neck sweatshirt, and sneakers made by the Swiss brand On. He does not have a degree in the hard sciences—as an undergraduate, he majored in Law, Letters, and Society at the University of Chicago—and was still in his twenties when he and two scientists founded Conception, which was initially known as Ovid Research. Krisiloff’s interest in I.V.G. was partly personal: he is gay, and liked the thought of one day being able to have biological children with a male partner. (Krisiloff once dated Altman; he is now in a relationship with Lucas Harrington, the co-founder of Mammoth Biosciences, which is focussed on the gene-editing technology CRISPR .)

While visiting Hayashi’s lab in Japan in 2018, Krisiloff met Pablo Hurtado González, a Spanish biochemist who was a visiting scholar there. Over dinner at a ramen restaurant in Fukuoka one evening, the mission of Conception began to take shape. Hurtado González, who is thirty-two, is also gay, and has a Ph.D. in reproductive health and a particular interest in male-male reproduction. (The bio on his Instagram profile reads “Trying to make genetic gaybies at Conception Bioscience.”) After placing an ad in Nature , Krisiloff and Hurtado González hired their third co-founder, Seres, who was born in Romania and raised in Hungary. She had worked as an embryologist at a fertility clinic in England before completing her Ph.D. at Cambridge University under Melina Schuh, a German cell biologist who is an expert in meiosis, the type of cell division unique to reproductive cells, which leads to the production of eggs and sperm. “Coming from I.V.F., in-vitro gametogenesis was the single most important solution to not having enough eggs,” Seres told me. Seres, who is thirty-six, has a daughter conceived without assisted reproductive technology, but her experience working at fertility clinics had made the issue personal to her: she had seen many patients with infertility issues for which no clear cause could be found.

Krisiloff had secured an initial million dollars from Hydrazine Capital, a fund, co-founded by Altman, in which he was an investor. (Conception’s investors now include Jaan Tallinn, the founder of Skype, and Laura Deming, who has a fund devoted to technologies that target the aging process to treat disease.) At first, Conception’s plan was more modest: to try to bring undeveloped eggs from a human to maturation in vitro. But a conversation with a surgeon convinced Krisiloff that immature eggs would be too difficult to extract. “One of our investors gave us really good advice, like, Hey, if in-vitro gametogenesis is the main thing you care about, you can probably go surprisingly far if you just choose to focus on that rather than defer it for later,” Krisiloff said. “That changed our trajectory.”

For now, Krisiloff is the only person at Conception who concentrates on the business side of things. He works alongside thirty-five scientists, many of them in their first jobs outside of academia; none are the kind of big-name principal investigators who tend to spin off private companies based on research in their own labs. “There’s some suspicion about the company aspect versus the academic approaches,” Krisiloff admitted. “Four or five years ago, it was, like, What are you kids doing here?” But, he added, “it became obvious early on that having teams of very specialized people working on different parts of this in parallel rather than having to think about their individual first-author publications would be quite helpful.”

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Still, in this era of disgraced tech-company wunderkinds and hubristic billionaires, Krisiloff seemed intent on avoiding the impression that he was another maverick tech entrepreneur—Mark Zuckerberg’s motto, “Move fast and break things,” does not inspire confidence when the desired outcome is a baby. Some observers have said that human biology is too complex for I.V.G. ever to become a viable method of reproduction, and I asked Krisiloff what would happen if they couldn’t make it work. “If we’re getting negative data in terms of in-vitro experiments or animal-safety testing, we’re not just going to try and brute-force it through,” he said. “We need to be cognizant that we’re trying to develop a technology that, if it does come to fruition, the impact is new human life.”

When I met Conception’s founders in January, the three kept up an easygoing banter. Krisiloff tends to defer to his co-founders for technical explanations. Seres, dark-haired and earnest, is analytic and adept at metaphor. Hurtado González, who is six feet five and has a thin mustache, speaks English with the sharp consonants of his native Spain and has had to become something of a scientist Jack-of-all-trades, managing the delivery of lab equipment between studying the latest published papers. He stood up at a certain point in the conversation to coördinate the burrito order for the company’s Friday lunch.

They clicked through slides depicting cells that had been stained to reveal their internal structures in bright magenta, blue, and green. Human egg cells begin their formation inside fetal ovaries in utero but start maturing individually only in adolescence, at the onset of menstruation. Conception’s researchers, who are trying to grow such cells through I.V.G., began by reprogramming blood cells, donated with consent for embryonic research, into stem cells, which can become any type of cell in the body. The stem cells are then programmed into primordial germ cells, the precursors to eggs. These germ cells are placed in dishes with lab-grown helper cells, which re-create the ovarian environment and are known collectively as ovarian organoids. The hope is that these helper cells will send out the necessary signals to coax the germ cells along in their development into mature eggs capable of being fertilized. The researchers use a variety of techniques, such as RNA sequencing, to insure that the lab-made cells are expressing the same genes that they would at a similar stage in the womb, and that they’re forming what are called follicles, the structures in the ovary in which immature egg cells develop.

On a cellular level, “the body” can become an abstract concept: as Krisiloff put it to me, “You don’t really need a heart to produce an egg.” You may not need the twelve or thirteen years that pass before an egg cell starts maturing in the body, either. If the germ cells are given the right signals, they will move on to the phase of development they would normally reach after puberty.

Conception has re-created many stages of egg development, but it had not yet put them all together into a single process that would culminate in a primary follicle, the phase that indicates an egg is ready to begin the final stages of maturation. “The prime focus right now is getting this follicle-formation step to occur,” Krisiloff said. “We think once we have this figured out, which we also think we’re relatively close to, then everything else we kind of have model systems for.”

Other researchers in the field are using the same techniques of stem-cell biology for different strategies. Some are trying to grow human eggs and sperm to test the toxicological effects of chemicals on gametes, or to develop contraceptive methods. Others are experimenting with how I.V.G. might result in cells that can be transplanted back into the body, such as spermatogonial stem cells (the precursors of sperm) for an infertile male.

Gameto, a New York-based biotech startup founded in 2020, is exploring in-vitro maturation: how to mature eggs that have been extracted from the body rather than made in a dish. It was co-founded by Martin Varsavsky, the owner of a chain of fertility clinics, and Dina Radenkovic, a physician turned entrepreneur. Unlike sperm cells, which most men produce in the hundreds of billions in the course of their lives, a woman is born with all the eggs she will ever have. These eggs mature slowly, normally just one per menstrual cycle. During I.V.F., women are given hormone injections that stimulate their ovaries to mature multiple eggs, but the process is onerous, and patients typically undergo anesthesia to retrieve the eggs.

When I spoke with Radenkovic, Gameto’s C.E.O., over video, she punctuated her points by holding up a follicle-stimulating injection pen of the kind used in I.V.F. “If you just had one man go through the brutal treatment of I.V.F., they would have sat down, they would have put some money in, and they would have solved it,” she said. If the process of freezing eggs becomes easier and more reliable, she continued, very few people would need to resort to I.V.G., which she sees as too risky a proposition for a business. “We’re really hopeful of allowing women to go through I.V.F. with much fewer side effects, less clinical time, and a lower cost—something that you could do in, like, egg-freezing kiosks. I see it almost like an extension of the beauty studio, where being proactive about your reproduction and longevity just seems like an act of self-care.”

Nearly everyone in the industry whom I spoke with, including Conception’s founders, told me that they regularly hear from people desperate to have biological children, volunteering to donate their genetic material or participate in clinical trials to test technologies that are likely years away. I spoke with someone who had contacted Conception, a forty-nine-year-old woman who lives in upstate New York. She told me her story—a childhood in England; a successful career as a lawyer; a long-distance partnership that began in her late thirties with a colleague who already had children and seemed reluctant to have more. She tried cycles of I.V.F., and all failed. “I grew up so ignorant about this—I was very focussed on my career, and I was a late developer romantically,” she said. When I asked why it was important to her to pass on her genes, she told me that after her parents died she wanted to have something of them to love in the world. “I have so much life and energy still to give,” she said. She would like to find a gestational carrier for her last frozen embryos. (Older maternal age at pregnancy is associated with a higher risk of complications.) “It’s a shame that it has to be this difficult.”

The morning after my visit to Conception, I was picked up at my hotel in San Francisco by Jennifer Garrison, a neuroscientist and an assistant professor at the Center for Reproductive Longevity and Equality. Garrison, who is blond and in her mid-forties, is one of the country’s foremost critics of the common narratives about female reproductive longevity. She is frequently quoted in the media and invited to lecture at conferences on the subject. She has been a consultant for companies exploring I.V.G., but she sees I.V.G. as only one piece in the much larger puzzle of female reproductive inequality. “If I had to sum up what we’re doing, I want aging in the female reproductive system to be synched up with aging in the rest of the body,” she told me, as we drove across a fog-wreathed Golden Gate Bridge. “If we can do that, then there are all these amazing, profound impacts on over-all health, not to mention fertility.” Menopause doesn’t just signal the end of fertility—it has negative impacts on bone health and on cardiovascular, cognitive, and immune function, and also causes weight gain, depression, insomnia, low libido, and other issues.

As we drove, Garrison apologized that the rainy weather was ruining the views. We were heading to the Buck Institute for Research on Aging, which sits atop a hill in a nature preserve in Novato, a small city in Marin County, overlooking San Francisco Bay; deer and wild turkeys roam the nearby fields. I. M. Pei, who designed the building, avoided right angles, on the theory that doing so would encourage creativity. The Center for Reproductive Longevity and Equality was started here in 2018, with a six-million-dollar donation from the foundation of the intellectual-property lawyer, entrepreneur, and investor Nicole Shanahan, who was then married to Sergey Brin, the co-founder of Google (they separated in 2021).

Shanahan was not yet thirty when she was told that she had polycystic ovary syndrome; at the time, she and Brin were trying to create an embryo through I.V.F. to bank. Informed that she was an impossible candidate, Shanahan walked away from the I.V.F. clinic believing that she was not going to be a mother. When, two years later, she conceived naturally, she didn’t take it as a lucky break; rather, she was infuriated about the guidance she’d been given and began to wonder why the subject was so poorly understood. Her experience became a cause. Shanahan has said that she sees extending reproductive longevity as “the natural and necessary progression of the women’s-rights movement.” In 2020, she funded a sister center in Singapore. (Many of the countries and regions with the lowest fertility rates in the world right now are in Asia.)

Much of the biology of female reproductive aging is still a black box: Garrison told me that we don’t know the timer or the cue that marks the beginning of reproductive decline, or why the age of menopause has so much individual variation. We have little sense of what aging in the ovaries means for aging in the rest of the body, even though early menopause is correlated with a shorter life span, not only for the woman experiencing it but for her brothers. There is currently no reliable biomarker that tells a woman how many eggs she has left.

Research into women’s health has historically been underfunded. Most of our contraceptives and fertility treatments were developed in the last century; there has been little innovation since the nineteen-eighties. Reproductive-health-care research has been further impeded by political controversies surrounding abortion, contraception, fetal tissue, and the “personhood” of embryos. Women were not required by law to be included in government-funded clinical research until 1993, and many drugs and dosages are still optimized for the male body. One 2021 study, “Gender Disparity in the Funding of Diseases by the U.S. National Institutes of Health,” which was published in the Journal of Women’s Health , found that, “in nearly three-quarters of the cases where a disease afflicts primarily one gender, the funding pattern favors males.”

Shanahan has advocated against supporting the I.V.F. industry and I.V.G. research, seeing them as circumventing much needed research into understanding the causes of infertility. Instead, she leads an investment firm, Planeta Ventures, and a foundation, Bia-Echo, which support the development of precision medicine, nutritional interventions, and diagnostic tools, which she hopes will give individuals a much better idea of when and for how long and why they can get pregnant, one that is not based on a population average. “I think that there has been a very big missing category of medical services,” she said. “Many of the I.V.F. clinics are financially incentivized to offer you egg freezing and I.V.F. and not incentivized to offer you other fertility services.”

Garrison concurred, going so far as to describe egg freezing as “barbaric.” She argued that the private for-profit I.V.F. industry masks as innovation what is in fact a symptom of neglect. “There’s been a huge amount of research funding, consumer dollars, and government subsidies that have gone into that industry in the last four decades, and not just in this country,” she said. “If even a tiny bit of that had gone into answering some of these basic questions that we’re talking about, we wouldn’t be having this conversation.”

After pausing to look at some nematode worms glowing under a microscope in Garrison’s lab, we examined a graph that showed average male fertility—a slope that barely wavers until the end of life—and average female fertility, with its steep decline beginning in one’s mid-thirties. “I hate this graph,” Garrison said. For one thing, she explained, it obscures the fact that many women have a much “noisier” trajectory, with fluctuating periods of fertility and infertility. It would be helpful, she suggested, if women had a better way to monitor intervals of fertility as they age. Instead, the graph is used as evidence of the inexorable.

She contemplated another approach. “What if we didn’t move the age of menopause, but right up until the age of menopause your eggs were healthy and there wasn’t this fifteen-year window where your risk of miscarriage, aneuploidy, birth defects, and infertility goes up?” she asked. “What if we could just X that out?”

The following weekend, I returned to the Buck Institute for a conference in which the organization’s grant recipients gathered to present their work. The future of reproductive technology, the presentations suggested, might include not just I.V.G. but a whole range of interventions: a scientist from Mexico gave a talk about the hyperproductive ovaries of ant queens, which can be fertile for as long as thirty years; another discussed a trial of the drug rapamycin to determine whether it prolongs fertility in rhesus macaques; another spoke about the role of gut microbiota in reproductive aging.

It was a lot to take in. The graph indicating the decline in female fertility relative to male was shown four or five times, as if we might forget. In the past few years, several of my male friends over the age of fifty have become fathers for the first time. Their reproductive freedom is their privilege and their right. One of these friends told me that going through psychoanalysis finally gave him the ability to have intimacy in his life. How luxurious to have that time. I am childless and turning forty-two this month. I have eleven oocytes—immature egg cells—in cryogenic storage in a facility somewhere in Manhattan. Right now, that’s pretty much all that science can offer a late bloomer with ovaries. The oocytes, should I ever attempt to have them fertilized and implanted, have a forty-per-cent chance of resulting in a successful pregnancy.

That night, the researchers gathered for dinner at a nearby winery. A professor of molecular biology from Princeton named Coleen T. Murphy told a story about how, twenty years ago, she pitched a fertility diagnostic blood test to an investor. She recalled him responding, “Can’t you just get that from a Pap schmear ?” Everyone laughed. I asked the others at the table—they were all women—if they were also concerned about research showing that sperm counts have declined worldwide. Murphy looked at me blankly. “But there’s still so many of them,” she said. “And, let’s be honest, they don’t even do that much,” an ob-gyn and research scientist chimed in. “I call them ‘the postmen of cells.’ ”

Conception’s founders have tried to apply an engineering approach to making eggs, in which an experiment is conducted over and over with slight modifications. To keep its researchers supplied, Conception has developed methods to make tens of millions of primordial germ cells and hundreds of ovarian organoids. During my visit, I watched as scientists checked the progress of cells under microscopes and pipetted liquids into dishes laid out across biosafety hoods, tweaking variables such as culture medium and timing. Bianka Seres told me that they keep mouse embryos in incubators with the dishes of cells; if the embryos stop growing, they know that something is wrong in the environment. Cells are temperamental—they don’t like plastic, or the cold.

One recent morning, I spoke by video with Katsuhiko Hayashi, one of the Japanese scientists who helped prove that I.V.G. was possible in mammals. It was six o’clock in the morning in Los Angeles, and ten o’clock at night in Japan, and Hayashi, who wore glasses and a sweater with a collared shirt, had his screen background blurred. I asked what he thought of the prospect of developing I.V.G. for human reproduction. “I think it takes a long, long time,” he said. “And even if we can get human oocyte cells in culture we need to carefully evaluate the quality of the oocytes, because even in the mice most of the oocytes are, how can I say, not potent enough to develop to a baby.”

Other academics, including those trying to make human eggs, are skeptical that startups such as Conception will supplant traditional scientific-research pathways. “If the end goal is only about getting to the tech, then yes, a biotech company has the advantage,” Amander Clark, a professor of molecular, cell, and developmental biology at U.C.L.A. who works on I.V.G., told me. “However, without an academic pipeline, there is no specialized and informed workforce to populate the biotech companies.” Clark points out that the industry has a long way to go: humans and mice are very different, and researchers have yet to prove that lab-made human cells can undergo meiosis in vitro.

Azim Surani, a developmental biologist at Cambridge and a mentor to many researchers in the field, explained some of the concerns: cells that look healthy and functional may still have unknown errors in their epigenome, and the long period of acculturation in dishes might result in the wrong modifications. Using skin or blood cells as the source of the DNA for the egg cell also risks introducing any mutations those cells have acquired during a person’s life—should I.V.G. become a reality, the best approach might begin with cells stored at birth. Among the parameters that will need to be evaluated in offspring, across multiple generations, are longevity, behavior, and susceptibility to disease.

“It’s going to take a lot of work to figure out how safe it is, and we’ll never know perfectly,” Henry Greely, the author of “The End of Sex,” told me. “I worry a lot that desperate people will try desperate things, that our regulatory system will not be up to it.” Other scientists feel that I.V.G. for human reproductive purposes may be jumping the gun—that researchers are attempting to create a process outside the body without fully understanding what takes place inside one. “Think of it this way,” Clark put it to me in an e-mail. “In the absence of this foundational scientific knowledge, it is the equivalent of trying to drive a car without a GPS to a destination that you have never traveled to before.”

The regulatory environment faced by a biotech startup like Conception is another unknown. “The United States has a political debate about abortion that has spilled over into everything that has to do with embryos,” Alta Charo, a retired professor of law and bioethics at the University of Wisconsin-Madison, told me. Federal law already prevents the government from funding the creation of human embryos for research, which means that funding for I.V.G. for human reproductive purposes has to come entirely from individual states, the private sector, or foreign entities. Also, in vitro-derived gametes for human use are likely to be regulated by the F.D.A. as a biological product; the F.D.A. cannot approve requests for clinical trials that would involve making heritable genetic modifications to human embryos, which may apply to some I.V.G. approaches. Charo predicts that human clinical trials for I.V.G. are far more likely to be first attempted in the U.K., which has a less polarized political climate around abortion, and a government agency, the Human Fertilisation and Embryology Authority, that licenses and monitors fertility clinics and provides recommendations about policy to lawmakers.

In 2021, the International Society for Stem Cell Research recommended extending the standard time limit on research done with in-vitro embryos, which is fourteen days, on a case-by-case basis. But such a step would come with its own thorny ethical questions. “Imagine a world where you could be doing research on an embryo very far along in development, but people can’t make any decisions about fetuses in their own bodies,” Sonia Suter, a professor of law at the George Washington University who studies bioethics and issues of reproductive technology, told me. She also feared a return to the idea that genetic connection is essential for families after decades of efforts by same-sex parents to be granted legal recognition of their relationships with their nonbiological children. Suter said that the technology would probably exacerbate existing inequalities. Because I.V.G. has the potential to create many more embryos than I.V.F., it may result in more screening for desired genetic traits. It is unlikely to be covered by many insurance plans, and attempts to optimize for health and success may primarily benefit the wealthy.

“It’s going to be the same parents who send their kids to private schools and get their kids in piano and ballet,” Suter said. “Then we have the opposite problem, where we have people who can’t get access to contraception and can’t terminate a pregnancy when they’re struggling financially.” She added, “That divide already exists. After Dobbs, it’s just going to get worse as we have more advanced technology.”

Paths to making a profit are uncertain. The inventors of I.V.F. never attempted to patent the technology, though the hormones injected in the process, which cost thousands of dollars, were patented by pharmaceutical companies. Conception has filed for a patent for some of the cells it has engineered, but, as Nature recently pointed out, the United States has laws against patenting the human organism, as well as medical procedures such as heart surgery or dialysis. Matt Krisiloff told me that, should Conception get governmental approval, its business model would be based on offering clinical services, which in the earliest stages might cost as much as two hundred thousand dollars per client.

Piraye Yurttas Beim, the C.E.O. of a biotech company called Celmatix, which is focussed on developing therapies to slow ovarian aging, told me that the excitement around I.V.G. could be misleading. “It feels like: we can go to Mars, so why can’t we make eggs?” she said. “But I think making eggs that have transgenerational reproductive potential—I think it’s probably, like, one hundred times as complex to do that as to go to Mars.”

I asked what she thought the options might be twenty years from now, if I.V.G. is not available. She described the world that she pictured for her daughter, who is six, in which assessment of ovarian and hormonal health will begin in young adulthood. “It’s going to be a standard part of her ob-gyn experience, from a place of optimizing for her long-term reproductive potential,” she said. Her daughter’s generation will likely freeze their eggs early, have babies in their forties or fifties, and anticipate living into their nineties. “It will feel completely arcane and mind-boggling for her that any generation before just simply went into menopause like it was an unavoidable thing,” she concluded. “That is going to feel as foreign to a woman in twenty years in the developed world as the pre-C-section or pre-birth-control era.”

In the weeks after I first visited Conception, researchers working under George Church, the well-known geneticist at Harvard, announced new breakthroughs in the creation of a human ovarian organoid. The research for the technology had been sponsored by Gameto, the New York-based startup, which then licensed it for use. I asked one of the researchers who worked on the project, a Ph.D. student named Merrick Pierson Smela, if he thought growing a stem-cell-derived egg in a dish would ever be possible. “Definitely,” he said, without hesitation. He added that the first person to do it is unlikely to be the one who captures the entire field. “Ten or twenty years after the first proof of concept is when you’re going to see actual human babies from it,” he estimated. Conception has not published papers, which makes it hard to know how Harvard’s organoid compares with its own, but the main difference between their approaches is that Conception is trying to use its organoids to grow egg cells made from stem cells, whereas Gameto, using Harvard’s technology, is creating what it calls “a signaling environment,” basically mimicking the ovaries, in which immature egg cells taken from the body will be placed and given the cues to mature, a potentially more attainable goal.

At the end of March, I returned to Conception for an update. A few weeks before, the staff had moved into a new office, in a renovated warehouse. Seres took me on a tour of the gleaming lab: an area filled with biosafety cabinets, incubators, and microscopes was devoted purely to the production of millions of primordial germ cells. We paused before a single-cell analyzer, a glossy black box the shape and size of a bread machine. It cost around ninety thousand dollars. Conception’s scientists also had news to share: they had brought their oocytes to the primary-follicle stage. “To our knowledge, nobody has been able to do that with in-vitro-derived germ cells,” Hurtado González said. “For us, that was one of the biggest bottlenecks, and it worked.”

“It’s very exciting,” Seres said. I asked if they planned to share the process with the broader scientific community. Krisiloff said they were still figuring out a way to do so that wouldn’t compromise their intellectual property, but that “obviously it’s extremely important for us that there’s general buy-in that we’re actually doing something legitimate.”

Hurtado González suggested that they might reveal only the follicle. “The morphology is excellent, it’s beautiful,” he said. They are now doing molecular analysis on the cells, he said, “to make sure they are what we would expect.”

That evening, the staff had a party to celebrate the move to the new space. In a play area in a corner, a few children took turns going down a plastic slide, and drawing pictures on a whiteboard. A karaoke machine had been set up for later in the night, and a projection screen on one wall featured images of the cells that Conception is growing, their colors brilliant with immunofluorescent staining. The cells were either the future of human reproduction or just something that was worth trying.

“It is valuable to show the possibility of such a new, let’s say alternative, type of reproduction for the future,” Katsuhiko Hayashi had said to me when we spoke over video. “But of course such a technology should be evaluated by the society.” ♦

An earlier version of this article inaccurately characterized historical death rates.

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Infertility articles from across Nature Portfolio

Infertility is the inability to conceive a child after a certain period of time – the length of which varies by country. The term can also refer to women who are unable to carry a pregnancy to term. Infertility has many different causes, including polycystic ovary syndrome and low sperm quality.

Latest Research and Reviews

Temporal effect of flaxseed oil in boar’s diet on semen quality, antioxidant status and in-vivo fertility under hot humid sub-tropical condition

• Mahak Singh
• R. Talimoa Mollier
• V. K. Mishra

Application of testicular organ culture system for the evaluation of spermatogenesis impairment

• Hideaki Nakagiri
• Takehiko Ogawa
• Masaaki Miyazawa

Premature ovarian insufficiency

Premature ovarian insufficiency (POI) is defined as the loss of normal ovarian activity before the age of 40 years, and is a cause of infertility and endocrine dysfunction in women. This Primer outlines the epidemiology and pathophysiology of POI, including associated gene variants, and discusses diagnosis, management and quality of life for women with POI.

• Philippe Touraine
• Nathalie Chabbert-Buffet
• Elena J. Tucker

Protein phosphatase 4 maintains the survival of primordial follicles by regulating autophagy in oocytes

• Ming-Zhe Dong
• Ying-Chun Ouyang
• Qing-Yuan Sun

Homozygosity for a stop-gain variant in CCDC201 causes primary ovarian insufficiency

Genome-wide analysis of age at menopause under a recessive model identifies a stop-gain variant in CCDC201 associated with primary ovarian insufficiency. This homozygous genotype is present in 1 in 10,000 women of northern European ancestry.

• Asmundur Oddsson
• Valgerdur Steinthorsdottir
• Kari Stefansson

Optimizing oocyte yield utilizing a machine learning model for dose and trigger decisions, a multi-center, prospective study

• Chelsea Canon
• Lily Leibner
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News and Comment

Pirna pathway disruption in human infertility.

• Maria Chiara Masone

Chromosome segregation in SCNT oocytes

• Louise Lloyd

Focusing on male infertility

The burden of male infertility is often unrecognized and its causes are poorly understood. Efforts to increase awareness and understanding are being undertaken to improve fertility outcomes and overall health for affected men.

Questionable role of new techniques in IVF embryo culture

Uninterrupted embryo culture and time-lapse monitoring are increasingly offered to people undergoing IVF — but a randomized study fails to show any benefit over routine embryo-selection methods.

• Karen O’Leary

Identification of pathogenic DNA variants in premature ovarian insufficiency

The largest whole-exome sequencing study of individuals with premature ovarian insufficiency (POI) so far identifies 20 new disease-associated genes, yields an overall genetic contribution to POI of 23.5%, and provides detailed characterization of the genetic landscape of this disorder.

An encounter with the mild side of LARS2 -associated Perrault syndrome and its implications on the diagnostic odyssey

• Barbara Vona

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Creating a sperm or egg from any cell? Reproduction revolution on the horizon

A clinician prepares cells for in vitro fertilization, or IVF, the treatment for infertility. In the future, it could be joined by IVG, in vitro gametogenesis, a new process that could turn any cell first into a stem cell and then into a sperm or egg cell. Lluis Gene/AFP via Getty Images hide caption

A clinician prepares cells for in vitro fertilization, or IVF, the treatment for infertility. In the future, it could be joined by IVG, in vitro gametogenesis, a new process that could turn any cell first into a stem cell and then into a sperm or egg cell.

It's a Wednesday morning at the National Academies of Sciences, Engineering and Medicine in downtown Washington, D.C., and Dr. Eli Adashi is opening an unprecedented gathering: It's titled "In-Vitro Derived Human Gametes as a Reproductive Technology."

It's the academy's first workshop to explore in-vitro gametogenesis, or IVG, which involves custom-making human eggs and sperm in the laboratory from any cell in a person's body.

"It is on the precipice of materialization," says Adashi, a reproductive biology specialist from Brown University. "And IVF will probably never be the same."

For the next three days, dozens of scientists, bioethicists, doctors, and others describe the latest scientific advances in IVG and explore the potentially far-reaching thicket of social, ethical, moral, legal and regulatory ramifications of the emerging technology. Hundreds more attend the workshop remotely.

"The implications here are huge," says Alana Cattapan , who studies reproductive health issues at the University of Waterloo in Canada.

The realization of the advance for humans likely is still years away, but the excitement about it among scientists is growing.

So far, healthy IVG mice

Japanese scientists describe how they've already perfected IVG in mice . The researchers used cells from the tails of adult mice to create induced pluripotent stem (iPS) cells, and then coaxed those iPS cells to become mouse sperm and eggs. They've even used those sperm and eggs to make embryos and implanted the embryos into the wombs of female mice, which gave birth to apparently healthy mouse pups.

"We are in the pathway of translating these technologies into the humans," says Mitinori Saitou from Kyoto University, addressing the group via Zoom.

In fact, Saitou says he's fairly far down that pathway. He's turned human blood cells into iPS cells, and used those iPS cells to create very primitive human eggs . Others have created primitive human sperm this way. Neither the sperm or eggs are developed enough to make embryos or babies. But scientists around the world are intensively working on that. "I've been really impressed with all the data that we've seen here and just how quickly this field is evolving," says Dr. Hugh Taylor , a reproductive health specialist at Yale School of Medicine. "It makes me confident that it's not a matter of if this will be available for clinical practice but just a matter of when."

'Life-altering' for infertility

Next, the workshop participants, who gathered at the end of April, explore the implications of IVG if the technology were ever to become a reality for humans.

"This could be life-altering for individuals to build that family that they dream of through IVG," says Andrea Braverman , who studies infertility at Thomas Jefferson University in Philadelphia. IVG would enable infertile women and men to have children with their own DNA instead of genes from the sperm and eggs or donors. Same goes for women of any age, rendering the biological clock irrelevant. But that, Braverman says, raises many questions.

"Yes it's great to be able to not to have to worry as woman that 40 is the cliff that we fall off of," she says. "But on the other hand: What are the implications for families? For the children that have parents that are older? I always think about freshman move-in day in your 80s." IVG could also enable gay and trans couples to have babies that are genetically related to both partners. "We too could point to our children and say, 'He has your eyes and my nose,' in a way that is something that I think many queer people covet," says Katherine Kraschel, who studies reproductive health issues at Yale Law School. But Kraschel also worries that could undermine acceptance of gay people parenting children who aren't genetically related to them through adoption or by using other peoples' sperm and eggs. "To the extent the IVG replaces markets in sperm and eggs, concerns about backsliding I think are really warranted," she says.

Provocative possibilities

Another theoretical possibility is "solo IVG" — single people having "uni-babies" — babies with just one person's genes, says Dr. Paula Amato , a professor of obstetrics and gynecology at the Oregon Health & Science University in Portland "In theory you could reproduce with yourself. And the resulting child would be 100 percent related to you," Amato says. "You could do that if you wanted to."

She warns, however, that may increase the risk for genetic problems in offspring.

At the same time, the DNA for IVG could be obtained from anywhere a single cell could be found, says Henry Greely , a bioethicist at Stanford.

That raises a long list of other provocative possibilities, he says, including "90-year-old genetic mothers, 9-year-old genetic mothers, 9-month-old fetuses that become genetic parents, people who've been dead for three years whose cells were saved who become parents." People could even potentially steal the DNA of celebrities from, for example, a clipping of their hair to make babies, he says. "One law we definitely need is to make sure people can't become genetic parents without their knowledge or consent," says Greely. Throughout the meeting, researchers and bioethicists warn that the ability to create a limitless supply of IVG embryos — combined with new gene-editing techniques — could turbo-charge the power to eradicate unwanted genes. That could help eradicate terrible genetic diseases, but also move "designer babies" even closer to reality. "The desire to genetically modify the future generation in a hunt for a assumed perfect race, perfect baby, perfect future generation is not science fiction," says Amrita Pande , a professor of sociology at the University of Cape Town in South African. "IVG when used with gene-editing tools like CRISPR should make us all worried."

IVG is probably still at least years away — and may never happen, several of the participants note. There are still significant technical hurdles that would need to be overcome, and questions about whether IVG could ever be done safely, several experts repeatedly warn during the workshop Nevertheless, the Food and Drug Administration is already exploring the implications of IVG, according to Dr. Peter Marks , a top FDA official. "It's an important technology that we are very interested in helping to move it forward," Marks says.

But Marks notes Congress currently prohibits the FDA from even considering any proposals that would involve genetically manipulated human embryos. "This creeps out our attorneys," Marks says. "It makes them feel uncomfortable in this space."

But if IVG remains off-limits in the U.S, Marks and others warn IVG clinics could easily spring up in other countries with looser regulations, creating a new form of medical tourism that raises even more ethical worries. That includes the exploitation of women as surrogate mothers.

"Does IVG really increase human well-being?" Pande asks. "Whose well-being does it increase?"

Others agree.

"The door that opens to this space is one in which so many things are unsettled," says Michelle Goodwin , director of the Center for Biotechnology and Global Health Policy at the University of California, Irvine. "So many ethical questions are yet to be unpacked."

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1 in 6 people globally affected by infertility: WHO

Large numbers of people are affected by infertility in their lifetime, according to a new report published today by WHO. Around 17.5% of the adult population – roughly 1 in 6 worldwide – experience infertility, showing the urgent need to increase access to affordable, high-quality fertility care for those in need.

The new estimates show limited variation in the prevalence of infertility between regions. The rates are comparable for high-, middle- and low-income countries, indicating that this is a major health challenge globally. Lifetime prevalence was 17.8% in high-income countries and 16.5% in low- and middle-income countries.

“The report reveals an important truth: infertility does not discriminate,” said Dr Tedros Adhanom Ghebreyesus, Director-General at WHO. “The sheer proportion of people affected show the need to widen access to fertility care and ensure this issue is no longer sidelined in health research and policy, so that safe, effective, and affordable ways to attain parenthood are available for those who seek it.”

Infertility is a disease of the male or female reproductive system, defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. It can cause significant distress, stigma, and financial hardship, affecting people’s mental and psychosocial well-being.

Despite the magnitude of the issue, solutions for the prevention, diagnosis and treatment of infertility – including assisted reproductive technology such as in vitro fertilization (IVF) – remain underfunded and inaccessible to many due to high costs, social stigma and limited availability.

At present, in most countries, fertility treatments are largely funded out of pocket – often resulting in devastating financial costs. People in the poorest countries spend a greater proportion of their income on fertility care compared to people in wealthier countries. High costs frequently prevent people from accessing infertility treatments or alternatively, can catapult them into poverty as a consequence of seeking care.

"Millions of people face catastrophic healthcare costs after seeking treatment for infertility, making this a major equity issue and all too often, a medical poverty trap for those affected,” said Dr Pascale Allotey, Director of Sexual and Reproductive Health and Research at WHO, including the United Nations’ Special Programme of Research, Development and Research Training in Human Reproduction (HRP). “Better policies and public financing can significantly improve access to treatment and protect poorer households from falling into poverty as a result.”

While the new report shows convincing evidence of the high global prevalence of infertility, it highlights a persistent lack of data in many countries and some regions. It calls for greater availability of national data on infertility disaggregated by age and by cause to help with quantifying infertility, as well as knowing who needs fertility care and how risks can be reduced.

Notes to editors

About the report

This report provides insight into global and regional infertility prevalence by analyzing all relevant studies from 1990 to 2021, taking into account different estimation approaches used.

The search identified 12 241 records of potentially relevant studies across the world. Screening of these records led to the selection of 133 studies that were included in the analysis for the report. From these, relevant data points were used to generate pooled estimates, for lifetime and period infertility prevalence.

New research on fertility treatment costs

Separately, new research funded by HRP and WHO and published in the journal Human Reproduction Open assessed the costs associated with infertility treatments in low and middle-income countries. This analysis found that the direct medical costs paid by patients for a single round of in vitro fertilization (IVF) are often higher than the average annual income – indicating prohibitive costs for most people in these parts of the world.

This research can be accessed at: https://academic.oup.com/hropen/article/2023/2/hoad007/7066921

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The Future of IVF: The New Normal in Human Reproduction

Vitaly a. kushnir.

1 Department of Obstetrics and Gynecology, University of California Irvine, 333 City Blvd, W. Ste. 1400, Orange, CA 92868 USA

Gary D. Smith

2 Departments of Molecular and Integrative Physiology, Obstetrics and Gynecology, Urology, University of Michigan, 4422 MS1 1301 E, Catherine St. Ann Arbor, MI 48109 USA

Eli Y. Adashi

3 Medical Science, Medicine and Biological Sciences, Brown University, 222 Richmond Street, Providence, RI 02903 USA

Associated Data

Not applicable.

Increased demand for in vitro fertilization (IVF) due to socio-demographic trends, and supply facilitated by new technologies, converged to transform the way a substantial proportion of humans reproduce. The purpose of this article is to describe the societal and demographic trends driving increased worldwide demand for IVF, as well as to provide an overview of emerging technologies that promise to greatly expand IVF utilization and lower its cost.

Introduction

Since its clinical introduction in 1978, in vitro fertilization (IVF) has redefined the ability of the human species to procreate. Initially developed to aid the infertile couple, clinical indications for IVF have since rapidly expanded to include medical and genetic conditions, as well as fertility preservation. While IVF access and utilization vary widely globally, the practice now accounts for the conception of over 5% of all newborns in some European countries where IVF is more affordable and/or is covered by insurance [ 1 ]. The corresponding figure presently stands at 4.1% in Australia and New Zealand, 1.9% in the USA, and 1.7% in China and is rapidly rising in all regions of the world [ 2 , 3 ]. Infertility, which affects approximately 10% of couples, remains the main driver of IVF utilization. These simple statistics suggest that IVF utilization may significantly grow in the coming decades if barriers to its utilization are lowered; this is without even considering an increasing number of indications for IVF beyond infertility.

Changing demographics and societal norms are driving increased IVF utilization. Improved access of women to educational and career opportunities, as well as effective contraception has contributed to progressively delayed childbearing and overall lower fertility rates worldwide. In many countries and in virtually all US states, fertility rates are now substantially below population replacement levels of 2100 births per 1000 women. In a growing number of metropolitan areas as well as in entire highly developed countries, the average age at first birth now exceeds 30 years, that is, well beyond peak fertility which occurs in the mid 20s. Inadvertently, a growing proportion of women is delaying childbearing to a point where age-related fertility decline contributes to the prevalence of infertility and to increased demand for fertility treatments including IVF and oocyte cryopreservation. These trends will likely accelerate due to the socio-economic impact of the COVID-19 pandemic, which has forestalled new family formation. Indeed, preliminary data from Chinese cities indicate that birth rates declined between 9 and 32.6% in the second half of 2020 compared with 2019, reflecting effects of the COVID-19 lockdowns [ 4 ]. Declining fertility rates in China have prompted its government to reverse a decades old one-child policy in favor of a two-child policy in 2016, and to a three-child policy in 2021.

The utilization of IVF is closely linked to its affordability and accessibility [ 5 ]. Indeed, a growing number of countries and US states are adopting various policies intended to reverse declining fertility rates. These policies range from legally mandated insurance coverage for fertility treatments to subsidies intended to ease the burdens of child-rearing. The concept that fertility is a basic human right is just starting to gain traction and is sure to accelerate wider adoption of such policies [ 6 ]. Another recent development is the growing number of prominent corporations opting to fund fertility benefits as a part of their social mission and as a means of attracting and retaining employees. Combined, the various policies that promote improved insurance coverage are bound to lower the cost of IVF to patients and increase its utilization.

The distribution of established fertility clinics thus closely corresponds to affluent metropolitan areas with the lowest fertility rates and the most advanced maternal ages at birth. Conversely, less densely populated and less affluent areas are characterized by relatively poor IVF access. Moreover, racial and ethnic disparities in the utilization of IVF, largely due to socio-economic factors, are inversely correlated with fertility rates [ 7 ]. An additional driver of IVF utilization is the growing societal acceptance of non-traditional families including single and same-sex parents. Finally, third-party IVF that includes the use of donor oocytes, sperm, or embryo and gestational carrier is rapidly growing, now accounting for over 20% of all birth conceived through IVF in the USA [ 8 ].

The IVF process is complex and stressful, it consists of multiple steps which can take up to several months to complete. The main reasons patient prematurely drop-out of IVF prior to achieving a pregnancy are the financial, physical, and psychological burdens of the treatment regimen [ 9 ]. Here, we describe promising future approaches and technological innovations which might improve IVF accessibility while reducing its costs and burden of care.

Medical Advancements

Controlled ovarian hyperstimulation (COH) is performed to increase the number of oocytes available for IVF. COH involves multiple injections of gonadotropins and serial visits to the fertility clinic for the conduct of transvaginal ultrasound evaluations and the measurement of circulating hormone levels. It follows that COH is complex, time sensitive, and intensive. Various strategies intent on reducing the number of injections by utilizing long-acting gonadotropins or oral medications are already available and are gaining increased acceptance in the field for the treatment of select patient populations [ 10 , 11 ]. Similarly, an emerging strategy to measure salivary estradiol levels may help decrease the need for blood draws during COH [ 12 ]. Recent advancements in portable lower cost ultrasound devices may further simplify follicular and endometrial monitoring by way of convenient mobile facilities and potentially even self-operated endovaginal telemonitoring [ 13 ]. Combined, these approaches may greatly simplify COH by rendering it less invasive and by decreasing the time commitment required. Finally, interventions which may further decrease the treatment burden may include screening of patients for psychological issues as well as offering counseling and coping interventions such as e-therapy as an integral part of IVF [ 14 , 15 ].

Technological Advancements

Perhaps the most promising technological development that might democratize IVF access in the near-term is the automation and miniaturization of the IVF laboratory. Building, staffing, and manually operating an IVF laboratory account for much of the high cost, maldistribution in access, and variability of outcomes. The basic steps in the IVF laboratory include:

• identification and separation of sperm and oocytes
• fertilization
• embryo culture
• embryo selection for transfer
• cryopreservation of surplus embryos and gametes

Great progress has already been made towards the automation of these individual steps by way of new technologies. Still, the IVF process in its entirety remains highly manual. The altogether novel IVF lab-on-a-chip concept has the potential to revolutionize IVF by enabling the automation of virtually all of the steps involved in a single system [ 16 – 18 ].

Microfluidics is defined as a multidisciplinary field of study and design whereby fluid behaviors are accurately controlled and manipulated with small scale geometric constraints that yields dominance of surface forces over volumetric counterparts. Past procedures in the IVF laboratory, though successful, apply a macroscale approaches to microscale cellular biological events [ 18 ]. Integration of microfluidics into the IVF laboratory may give rise to at least four foreseeable advantages: (1) precisely controlled fluidic gamete/embryo manipulations; (2) providing biomimetic environments for culture; (3) facilitating microscale genetic and molecular bioassays; and (4) enabling miniaturization and automation. The basic utility and advantages of individual microfluidic devices for gamete and preimplantation embryo isolation, manipulation, and assessment have been demonstrated [ 18 ]. Current efforts are focused on integrating extant individualized microfluidic procedural components into a future IVF lab-on-a-chip.

Microfluidic sperm-sorting devices [ 19 – 21 ] and automated sperm analyzers [ 22 ] are already being introduced into routine IVF practice. Indeed, microfluidics has been used for the isolation of sperm from semen and testicular biopsies [ 23 – 29 ]. These novel sperm-isolating microfluidics devices provide for the collection of highly motile sperm populations replete with enriched normal morphology, and most importantly, reduced DNA fragmentation relative to conventional methods of sperm isolation [ 19 , 27 , 30 , 31 ].

Microfluidic in vitro insemination has been demonstrated [ 32 ], whereas conventional fertilization is suitable for the vast majority of IVF patients, microfluidic systems may further decrease the need for Intracytoplasmic Sperm Injection (ICSI). Such outcomes may even be possible in the setting of oligospermia, because even a low concentration of sperm may still be sufficient to achieve fertilization [ 32 ]. As ICSI has become a dominant method of insemination in human clinical IVF, the importance of precise microfluidic push/pull cumulus-oocyte-complex cumulus cell removal has been shown to yield good visualization of the oocyte cytoplasm/orientation [ 33 ]. The fertilization step by ICSI is perhaps the most technically difficult step to achieve on a commercial scale, but feasibility of one such system has been demonstrated [ 34 ]. Future automated ICSI will likely involve a combination of microfluidics, robotics, and refined optics [ 34 , 35 ].

Embryo culture has already been fully automated with use of time-lapse incubators which allow continuous monitoring of embryo development. Data generated from time-lapse incubators can be analyzed with machine learning to aid in the selection of embryos with the highest pregnancy potential [ 36 – 38 ]. Additional information about embryo viability may be gleaned from other omics technologies which can either sample the embryo directly or indirectly via its culture media. The technologies in question include genomic, transcriptomic, proteomic, and metabolomic analyses [ 39 ]. Although the use of preimplantation genetic testing (PGT) of trophectoderm cells of blastocyst stage embryos is quite common in clinical practice, the utility of such testing for the ascertainment of aneuploidy remains controversial on both biological and technical grounds [ 40 ]. Microfluidics technology has been successfully used to culture mammalian preimplantation embryos from the zygote to the blastocyst stage both individually and in groups [ 41 – 46 ]. These experiments have proven informative to overcoming the hurdles of microenvironment manipulations in microfluidic devices involving microchannels [ 42 ], microfunnels [ 45 ], microwells [ 44 ], and microdroplets [ 46 ] that can induce shear stresses and osmotic shifts that can be detrimental to embryo development [ 45 , 47 ]. The importance of individual embryo culture in microfluidic devices can be appreciated when one considers the desire to integrate real-time imaging and morphometrics [ 48 ], molecular [ 49 ], and/or metabolomic [ 50 , 51 ] bioassays, biomechanics [ 52 ], and non-invasive PGT of cell-free DNA in spent media [ 53 ]. Noninvasive PGT, which utilizes cell-free DNA released into the spent embryo culture media, is likely to become the first omics technology used clinically in conjunction with a microfluidic system [ 53 ].

Finally, cryopreservation of sperm, oocytes, and embryos has become the standard of care. Vitrification has become the dominant method for oocyte and embryo cryopreservation. While semi-automated/automated systems for oocyte/embryo vitrification have been reported and are now in early stages of clinical adoption [ 54 – 56 ], these devices do not necessarily use or require microfluidics. If one looks to the future of a microfluidic automated lab-on-a-chip, the question arises of whether or not microfluidics is useful and/or beneficial in the vitrification process? Microfluidics can be used to precisely control cryoprotectant exposures (gradual versus step-wise exposure) to oocytes/zygotes/embryos and thus reduce osmotic strain, reduce sub-lethal membrane damage, and improve subsequent development [ 57 – 60 ]. Future potential benefits of integrating microfluidics with vitrification and automation have been carefully enumerated in recent reviews [ 59 , 61 , 62 ]. Integrated microfluidics for vitrification with automation is promising. Such a system/device will reduce reagent consumption, decrease labor intensity, facilitate ease of use, offer medium to high throughput, and may foster point-of-care cryopreservation and/or promote in-office cryopreservation procedures that require less in the way of technical/personnel expertise and sophisticated laboratory/equipment needs.

Figure  1 illustrates the future IVF lab-on-a-chip concept, including all of the laboratory steps performed during IVF while integrating emerging non-invasive techniques of embryo assessment. Adoption of automated IVF systems offers multiple potential advantages: standardization of workflows, reduction in errors, reduction in cost, reduction in contamination, and the potential for incremental system improvement via machine learning. Additionally, miniaturization and automation of the IVF laboratory can greatly improve accessibility to IVF treatment for underserved communities, especially those who are economically disadvantaged and who reside in rural areas. Regulatory approval will doubtlessly be required if automated systems are to be adequately validated to produce clinical outcomes superior to those attained with the current manual process in the IVF laboratory. Furthermore, automation will likely significantly decrease the staffing requirements and alter the type of skills required to operate fertility centers. It is likely that the technical aspects of IVF will be gradually assumed by machines. This may well increase the emphasis placed on human interactions which supports the medical and psychological needs of patients during their fertility journey.

Future IVF lab-on-a-chip concept displaying the integration of all the steps performed during the IVF process and of emerging non-invasive techniques of embryo assessment

Scientific Advancements

Fertility preservation research has steadily increased our understanding of the mechanisms that govern folliculogenesis [ 63 ]. The development of in vitro culture systems for follicles provided insights into the relationship between oocytes and their surrounding somatic cells, as well as the requisite hormones and growth factors. Multi-step culture systems have advanced to a point where primordial follicles residing in ovarian cortical tissue can undergo activation, growth, and in vitro maturation (IVM) to yield metaphase II (MII) oocytes [ 64 ]. These advancements are expanding fertility preservation via ovarian tissue cryopreservation and subsequent chance at parenthood via IVF to pre-pubertal girls and young women at-risk to develop primary ovarian insufficiency (POI) due to gonadotoxic chemotherapy for cancer or due to other serious diseases. Intriguing extensions of this technology may enable the isolation of oocytes from patients who have already developed POI or have entered natural menopause so long as some dormant follicles remain within their ovarian cortex. Another avenue of research is to develop an artificial ovary as has been achieved in a murine model using 3D printed scaffolds for tissue engineering [ 65 , 66 ]. Microfluidic culture systems may also be utilized to support follicle development while mimicking the natural menstrual cycle [ 67 ].

In Vitro Gametogenesis (IVG)

Perhaps the most revolutionary concept in modern reproductive science is that of in vitro gametogenesis (IVG). IVG comprises various approaches, including organ culture systems, embryonic stem cells (ESC), induced pluripotent stem cells (iPSC), and spermatogonial stem cells (SSCs). Several of these approaches led to the creation of functional gametes in rodent models [ 68 ]. Japanese scientists, who have been at the forefront of IVG research, have recently succeeded in extending these techniques to the generation of human oogonia from iPSCs [ 69 ]. Yet, another approach to IVG involves reconstruction of functional oocytes by nuclear transfer of the first polar body genome from an MII oocyte into an enucleated donor MII cytoplasm [ 70 ]. This latter technique may well increase the number of oocytes available for the treatment of infertility of women with few or poor-quality autologous oocytes.

The existence of human oogonial stem cells (OSCs) capable of giving rise to new oocytes has been an area of some controversy for nearly a decade. Reports to the effect that cells isolated from human ovarian tissue using fluorescence-activated cell sorting and an antibody against the DDX4 protein constituted OSCs challenged the long-standing dogma that the ovarian reserve is finite [ 71 , 72 ]. Multiple follow up studies by several groups were unable to confirm the presence of OSCs in the human ovary. Recently, single-cell analysis of the human ovarian cortex failed to identify OSCs [ 73 ]. Instead, cells captured by the DDX4-directed antibody proved to be perivascular cellular elements [ 73 ].

SSCs constitute the progenitor cells in the process of spermatogenesis. As such, these cells are the focus of in vitro spermatogenesis (IVS) and in vivo restoration of male fertility. While IVS has been achieved in rodent models, it has proven far more difficult to realize in primate counterparts [ 74 ]. One recent approach to IVS involved the culture of SSCs with immortalized Sertoli cells. Meiosis and the production of spermatid-like cells followed, albeit in the face of improper activation of cognate meiotic checkpoints [ 75 ]. In yet another approach, sperm nuclear transfer allowed production of androgenetic haploid embryonic stem cells which were able to “fertilize” oocytes and support early embryonic development, diploid blastocysts, and ESC generation [ 76 ]. Once fully realized, IVS is destined to offer genetic parenthood via IVF to infertile men diagnosed with azoospermia and pre-pubertal boys undergoing gonadotoxic treatments.

Reproductive Genetics

The convergence of IVF with reproductive genetics has been at the forefront of the field for the past few decades. The development of next generation sequencing has expedited the adoption of PGT of embryos with an eye toward detecting the presence of chromosomal abnormalities. Moreover, increased use of carrier screening of infertile couples has increased the use of PGT for monogenic diseases. As cost of carrier screening decreases and the number of detected mutations expands, a substantial new population of patients identified as carriers may pursue IVF with PGT to build their families. Indeed, population genomic screening of young adults may offer significant healthcare savings through the prevention of rare disorders and cancers [ 77 ]. Future applications of PGT may expand to multifactorial diseases and whole-exome screening, though current attempts at introduction of embryo selection based on polygenic scores into clinical practice seem premature and fraught with ethical challenges [ 78 ]. Recent improvements in micromanipulation techniques and the development of CRISPR-Cas9 gene editing tools [ 79 ] raise the prospect of germline genome modification (GGM) for severe monogenic disorders. Indeed, GGM has already been achieved in human embryos [ 80 ]. Mitochondrial replacement therapy (MRT) for the prevention of heritable mitochondrial DNA diseases is even further developed than GGM, with clinical trials already underway in the UK [ 81 ].

The growing utilization of IVF will transform the way a substantial proportion of the human species procreates. It is likely that in the near future, as many as 10% of all children will be conceived through IVF in many parts of the world. Given the rapid scientific and technological evolution of IVG and of reproductive genetics, it is imperative that both the public and regulatory bodies be engaged in establishing a framework for the ethical evaluation of emerging technologies [ 82 – 84 ]. Such public engagement is critical. The absence of such may well result in reactionary bans against clinical research as has been the case for GGM and MRT in the USA [ 85 ]. Moreover, the introduction of innovative technologies into clinical practice must be rooted in science and supported by well-designed clinical trials [ 86 ]. Premature commercialization of costly and unproven “add-ons” to IVF has been an ongoing issue in the field, ranging from procedures to medicines to laboratory techniques [ 87 , 88 ]. Collectively, routine application and marketing of unproven IVF add-ons may erode the public trust in the reproductive medicine field. Thus, it is imperative for the field to prioritize requiring confirmation of safety and efficacy of technologies before allowing them to be offered routinely to IVF patients. Reproductive medicine, and especially IVF, is rapidly transforming human reproduction and is thus bound to remain of fundamental importance to both science and society.

Abbreviations

Data availability

Code availability, declarations.

The authors consent.

Dr. Kushnir is an inventor on patents related to clinical use of recombinant anti-müllerian hormone and a consultant for medical insurance companies. Professor Smith is an inventor and jointly holds patents with the University of Michigan related to microfluidics and gamete isolation, in vitro fertilization, embryo culture and cryopreservation. Dr. Smith served as consultant for Overture Life.

Contributor Information

Vitaly A. Kushnir, Email: ude.icu.sh@rinhsukv .

Gary D. Smith, Email: ude.hcimu@dghtims .

Eli Y. Adashi, Email: ude.nworb@ihsada_ile .

Genetic variants influencing human fertility identified - new research

How many children an individual may have is influenced by reproductive biology and human behaviour, according to the largest study to date, which identifies genetic determinants. The study, led by researchers at the Universities of Cambridge, Oxford and Pennsylvania, also identified that the human genome has been influenced by natural selection for thousands of years and continues to affect fertility today.

The findings demonstrate that fertility is affected by diverse biological mechanisms, which contribute to variations in fertility, and directly affect puberty timing, sex hormone levels (such as testosterone), endometriosis and age at menopause. There were also links to behaviours such as risk taking.

It empirically tests one of the most gripping and fundamental questions asked by scientists...Is there evidence of ongoing natural selection in humans and, if so, what is it and how does it operate? Professor Melinda Mills

Professor Melinda Mills , Director of Oxford’s Leverhulme Centre for Demographic Science, comments, ‘This study is of interest to understanding changes in human reproduction over longer periods of time, reproductive biology and potential links to infertility.’

‘It also empirically tests one of the most gripping and fundamental questions asked by scientists across many disciplines and decades: Is there evidence of ongoing natural selection in humans and, if so, what is it and how does it operate?’

The major study, published today in Nature Human Behaviour, used data from 785,604 individuals of European ancestry, including individuals in the UK Biobank study, to identify 43 regions of the genome containing genetic variants associated with reproductive success, defined as the number of children ever born to an individual.

Some findings highlight trade-offs across the life-course, for example, the researchers found variations in the gene ARHGAP27 that were associated with having more children, but also with a shorter lifetime window of fertility. The analysis also suggested a novel role for the red hair colour gene, melanocortin 1 receptor (MC1R) in reproductive biology. But the genetic evidence suggests the influence on number of children is not related to the same genetic mechanisms that affect pigmentation.

[It] will help identify novel therapeutic targets for reproductive diseases such as infertility. It will also help us better understand the biological mechanisms that link reproductive health to broader health outcomes in men and women Professor John Perry

Professor John Perry, MRC Epidemiology Unit, University of Cambridge notes, 'This study is the largest of its kind and has highlighted new biology that we anticipate will help identify novel therapeutic targets for reproductive diseases such as infertility. It will also help us better understand the biological mechanisms that link reproductive health to broader health outcomes in men and women.'

By integrating their findings from modern genomes with ancient genome data, the researchers were able to identify a region of the genome that has been under selection for thousands of years, and remains under selection today.

The genes in this region - FADS1 and FADS2 - are involved in synthesising specific fats that are important for health and seem to have been important in helping people in Europe to adapt to an agricultural diet. The observation that these genes still affect fertility today suggests that this adaptation may be ongoing.

Dr Iain Mathieson, Department of Genetics, University of Pennsylvania, points out, ‘Independent evidence shows the FADS region has been under selection in Europe for thousands of years. It represents the clearest example of a genetic variant with evidence of both historical and ongoing natural selection, though the reason for selection remains unclear.

It represents the clearest example of a genetic variant with evidence of both historical and ongoing natural selection, though the reason for selection remains unclear Dr Iain Mathieson

Read the Nature Human Behaviour paper: ‘Genome-wide analysis identifies genetic effects on reproductive success and ongoing natural selection at the FADS locus’ here .

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What's really behind the male infertility crisis? New study seeks answers

• Download PDF Copy

In a recent study published in the journal Nature Reviews Urology , researchers addressed the most pertinent questions concerning male infertility. They discussed the current understanding of the subject, as well as the areas and opportunities for improving male reproductive health.

Although the incidence of infertility among middle-aged men and women is almost equal, the dearth of understanding about aspects related to male gamete production and the impact of lifestyle and environmental factors has resulted in a lack of clarity about the etiology of male infertility. The health system also fails to understand the importance of male infertility as a biomarker for other systemic illnesses or the benefits of improved knowledge of male reproductive health in medically assisted reproduction (MAR) technology.

The tests to precisely diagnose male infertility are still rare, and infertility is mainly diagnosed using family histories, semen analyses, physical examinations, and surrogate markers in the form of hormone profiles. Furthermore, the categories used to group men who seek MAR are broad, such as azoospermia, asthenozoospermia, oligozoospermia, and teratozoospermia, which can have multiple underlying causes. The lack of clarity about male infertility makes it difficult to treat the condition and often results in the female partner being misassigned the burden of treatment in cases of infertile couples seeking MAR.

About the study

In the present study, the researchers emphasize the need for a better understanding of the underlying causes of male infertility, such as an interplay of epigenetic and genetic factors and the influence of lifestyle choices and environmental factors. Furthermore, they believe that the issue of male infertility extends beyond the conception of offspring and also impacts other aspects of health, with studies indicating that the disease burden is higher among infertile men than fertile men. The need to better understand male infertility is imperative also from the perspective of ensuring that children conceived through MAR do not inherit the genetic factors that cause male infertility.

The present review was a result of a request from the Male Reproductive Health Initiative (MRHI) , which is part of the European Society of Human Reproduction and Embryology, for a recommendation document that could provide clarity on the current knowledge about male reproductive health and medicine, and identify research gap areas for further improvement. This document is intended for researchers in the field, as well as the governments and general public. The recommendations address some of the most pertinent questions related to male infertility and are a result of consultations with experts in the field of andrology research, public policy, and clinical practice from across the globe.

The researchers identified 13 of the most vital questions regarding male infertility and addressed these questions with the aim of improving the understanding, diagnoses, and treatment options for male infertility. The first question addresses the global prevalence of male infertility, and surprisingly, there is a lack of clarity on the subject. An accurate estimation of the prevalence of male infertility has proven difficult because most of the information comes from data from infertility clinics or from studies examining populations that are at risk, such as those exposed to specific toxins.

Furthermore, assessments of male infertility are based on semen analysis from heterosexual couples seeking MAR. The prognostic ability of semen analysis is not accurate, and the ability to conceive is based on the combined fertility of the couple. Therefore, in many cases, men with impaired spermatogenesis and reduced fertility still manage to conceive if their female partner is healthy, and cases often come to light only if the female partner also suffers from reduced fertility.

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With regard to diagnostic techniques, the review discussed the combination of methods currently used to diagnose male infertility but highlighted the lack of clarity in determining the causality of the cellular or physiological deficits identified through these tests.

The other areas of concern discussed in the review included the current treatment options that exist for addressing male infertility and the need for improved options. The review also discussed the genetic factors, as well as the lifestyle choices and environmental factors that impact male fertility. Epigenetic factors and their influence on male fertility and the inter-generational consequences of these epigenetic factors were also discussed.

Some of the other aspects of male reproductive health addressed in this review were the economic burden, as well as the disease burden, of male infertility and the possibility of developing gamete storage or restoration protocols before the administration of medical interventions.

The study also addressed the long-term impact of compromised fertility on the health of children conceived naturally or through assisted reproduction to men with impaired fertility. Lastly, the researchers addressed the need for improved communication about andrology and male infertility with health professionals, policymakers, funding agencies, and the general public.

Conclusions

Overall, this comprehensive review on male reproductive health addressed the significant areas of research, including a better understanding of the prevalence of male infertility and improved diagnosis and treatment methods. The researchers also discussed the need to understand the underlying causes of male infertility and to improve the communication of information about andrology to various stakeholders and the general public.

• Kimmins, Sarah, et al. “Frequency, Morbidity and Equity — the Case for Increased Research on Male Fertility.” Nature Reviews Urology , 2023, https://doi.org/10.1038/s41585023008204 , https://www.nature.com/articles/s41585-023-00820-4

Posted in: Men's Health News | Medical Research News | Medical Condition News

Tags: Andrology , Biomarker , Children , CLARITY , Conception , Diagnostic , Embryology , Fertility , Frequency , Genetic , Hormone , Infertility , Inherit , Male Infertility , Medicine , Reproduction , Reproductive Health , Research , Semen , Technology , Toxins , Urology

Dr. Chinta Sidharthan

Chinta Sidharthan is a writer based in Bangalore, India. Her academic background is in evolutionary biology and genetics, and she has extensive experience in scientific research, teaching, science writing, and herpetology. Chinta holds a Ph.D. in evolutionary biology from the Indian Institute of Science and is passionate about science education, writing, animals, wildlife, and conservation. For her doctoral research, she explored the origins and diversification of blindsnakes in India, as a part of which she did extensive fieldwork in the jungles of southern India. She has received the Canadian Governor General’s bronze medal and Bangalore University gold medal for academic excellence and published her research in high-impact journals.

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New pill can increase chances of IVF success, study finds

The "simple-to-take" drug acts directly on the inner lining of the womb to improve the embryo implantation process during fertility treatment, research suggests.

Monday 8 July 2024 09:16, UK

A pill for couples struggling to conceive with IVF treatment has been found to increase the chances of pregnancy, scientists say.

Researchers said initial trials of the drug - known as OXO-001 and created by Spanish biotech company Oxolife - showed "promising" results.

It acts directly on the inner lining of the womb to improve the embryo implantation process during fertility treatment.

Around 96 infertile women who were aged 40 or under and were receiving fertility treatment - either IVF or intracytoplasmic sperm injection (ICSI) with donor eggs - at 28 centres across Europe took part in the new study, between September 2021 and January 2023.

They were either given a placebo or OXO-001 - taken twice daily, one menstrual cycle before the embryo transfer and five weeks after.

Researchers found "ongoing pregnancy rates" measured 10 weeks after embryo transfer were 46.3% for patients treated with OXO-001 - compared with 35.7% for those given a placebo.

Keep up with all the latest news from the UK and around the world by following Sky News

This is a "clinically significant finding", they said, presenting their study to the European Society of Human Reproduction and Embryology's (ESHRE) 40th annual meeting in Amsterdam.

They said there was also a clinically meaningful increase in the number of women who went on to have a live birth.

The live birth rate was 42.6% for women who took the new pill compared with 35.7% among those who took the placebo, according to the study - also being published in the journal Human Reproduction.

Women in both groups suffered similar side-effects including headaches, nausea, vomiting, gastrointestinal issues and dizziness - most of which were mild to moderate.

The drug had already gone through safety checks in early studies - known as pre-clinical trials.

It is now to be tested on a larger group of women, including those who are using their own eggs.

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Oxolife chief executive Dr Agnes Arbat said: "Most rounds of IVF or ICSI still end in failure - many because a viable embryo does not implant.

"A simple-to-take pill that materially improves the chance of success would therefore be of huge benefit to those who want a baby. This proof-of-concept phase two study shows that hope is now a step closer."

She added: "This study was purposefully designed to include only women who used donor eggs so it could single out the true effect of OXO-001 on the endometrium.

"However, we believe OXO-001 has the potential to work equally well in those using their own eggs, and we are already planning a pivotal phase three clinical trial in this more extensive group to support product registration."

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Male Infertility: New Developments, Current Challenges, and Future Directions

Affiliations.

• 1 Department of Urology, Selcuk University School of Medicine, Konya, Turkey.
• 2 Global Andrology Forum, Moreland Hills, OH, USA.
• 3 Urology Section, University of Catania, Catania, Italy.
• 4 Fakih IVF Fertility Center, Abu Dhabi, UAE.
• 5 Reproductive Biology, Fertility Preservation, Andrology, CECOS, Poissy Hospital, Poissy, France.
• 6 Paris Saclay University, UVSQ, INRAE, BREED, Jouy-en-Josas, France.
• 7 Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University, Sohag, Egypt.
• 8 Ajyal IVF Center, Ajyal Hospital, Sohag, Egypt.
• 9 Department of Urology, Princess Alexandra Hospital, University of Queensland, Brisbane, QLD, Australia.
• 10 Department of Reproductive Urology, Austin Fertility & Reproductive Medicine/Westlake IVF, Austin, TX, USA.
• 11 Department of Andrology, Sexology and STIs, Faculty of Medicine, Cairo University, Cairo, Egypt.
• 12 Department of Urology, Lilavati Hospital and Research Centre, Mumbai, India.
• 13 Well Women's Centre, Sir HN Reliance Foundation Hospital, Mumbai, India.
• 14 Cleveland Clinic, Cleveland, OH, USA. [email protected].
• PMID: 38164030
• PMCID: PMC11216957
• DOI: 10.5534/wjmh.230232

There have been many significant scientific advances in the diagnostics and treatment modalities in the field of male infertility in recent decades. Examples of these include assisted reproductive technologies, sperm selection techniques for intracytoplasmic sperm injection, surgical procedures for sperm retrieval, and novel tests of sperm function. However, there is certainly a need for new developments in this field. In this review, we discuss advances in the management of male infertility, such as seminal oxidative stress testing, sperm DNA fragmentation testing, genetic and epigenetic tests, genetic manipulations, artificial intelligence, personalized medicine, and telemedicine. The role of the reproductive urologist will continue to expand in future years to address different topzics related to diverse questions and controversies of pathophysiology, diagnosis, and therapy of male infertility, training researchers and physicians in medical and scientific research in reproductive urology/andrology, and further development of andrology as an independent specialty.

Keywords: DNA fragmentation; Epigenomics; Infertility, male; Spermatozoa.

Copyright © 2024 Korean Society for Sexual Medicine and Andrology.

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Conflict of interest statement

The authors have nothing to disclose.

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Leading Scientist in Women's Reproductive Health Named Chief Scientific Officer of the Inception Research Institute

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Sep 24, 2024, 09:00 ET

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Gaurang Daftary , MD, brings more than 20 years of scientific experience to his role at the Inception Research Institute

HOUSTON , Sept. 24, 2024 /PRNewswire/ -- Inception Fertility ™ (Inception), North America's largest provider of fertility services, announces today that Gaurang Daftary , MD, has been named Chief Scientific Officer of the Inception Research Institute .

Established in 2022, the Inception Research Institute elevates the field of reproductive medicine by addressing the industry's most urgent needs, including cutting-edge advances in patient care through pharmacological innovations and device development, improving access to care, professional development and advancement, and innovative studies which investigate the relationships between treatment success and controllable entities such as lifestyle habits and emotional health.  

The Institute also supports the clinical research of The Prelude Network ™ (Prelude), Inception's clinical network of top-tier fertility practices across North America , by providing centralized services such as IRB applications, contract review, and recruitment support.

As Chief Scientific Officer, Dr. Daftary will support the Institute's research programs by initiating new trials with pharmaceutical, device, and laboratory sponsors, including multi-center FDA randomized controlled trials. He will also use the most extensive EMR database in North America to help determine the most effective protocols for specific patient populations to increase pregnancy rates and outcomes across the network.

"In the short time since we launched the Inception Research Institute, our team has embarked on and invested in exciting studies that can help us better understand how we can improve some of the important aspects of reproductive medicine, including how AI can improve treatment outcomes to investigating the impact of physiological manifestations of stress on IVF cycle outcome," says Alice Domar , PhD, Chief Compassion Officer at Inception and the Director of the Inception Research Institute . "We are very excited to have Dr. Daftary be part of this exciting new chapter of our Institute and help uncover new therapeutics to improve pregnancy outcomes."

Echoing Dr. Domar's sentiments, TJ Farnsworth, Founder and CEO of Inception Fertility , shares, "Welcoming Dr. Daftary to the Inception Research Institute expands the critical work we are doing to advance the science of reproductive medicine. We are thrilled to have him as part of our research team, and we look forward to the contributions he will undoubtedly bring to this field of medicine."

Dr. Daftary brings to the Institute over two decades of innovative scientific research in women's reproductive healthcare. He currently serves as the CEO of NextGenRepro, which provides consulting, strategy, and complex problem-solving in reproductive medicine and women's health in the medical and pharmaceutical industries. Before launching NextGenRepro, Dr. Daftary was the Global Scientific Vice President of Reproductive Medicine and Maternal Health at Ferring Pharmaceuticals.

"Over the last 20 years, we have seen the greatest advancements in reproductive medicine that are helping more and more people have babies. And yet, we recognize that there are many more opportunities to uncover even greater possibilities," says Dr. Daftary . "I am honored to be part of the Inception Research Institute and help bring these advancements to the forefront of the industry."

To learn more about the Inception Research Institute, please visit inceptionfertility.com/inception-research-institute/ . You can see a full of active research studies by visiting fertilitystudies.com . 

About Inception Fertility™

Inception Fertility ™ (Inception) is a family of fertility brands committed to helping patients build their own families. Built by patients for patients, Inception's purpose is to achieve the highest bar in experience, science and medicine in an effort to enhance each patient's experience and achieve better outcomes. 

Inception's medical experts are leading pioneers in fertility care. Our doctors are some of the first to use breakthrough assisted reproductive technologies (ART) – including in vitro fertilization (IVF), preimplantation genetic testing (PGT) and fertility preservation services – and they continue to lead the industry by building on these technologies by through development, research and thought leadership. 

Through its growing family of national organizations – which includes  The Prelude Network ®, the fastest-growing network of fertility clinics and largest provider of comprehensive fertility services in North America;  MyEggBank ®, one of the largest frozen donor egg banks in North America;  BUNDL Fertility ™, a multi-cycle fertility service bundling program;  HavenCryo ™, a long-term reproductive preservation and storage solution provider and  NutraBloom ®, a premium lifestyle brand with expertly formulated supplements to support individuals' health and wellness goals for preconception – Inception is working to deliver on its promise to push the envelope of what is possible for exceeding patient expectations. 

About The Prelude Network®

The Prelude Network ® (Prelude), the fastest-growing network of fertility clinics and largest provider of comprehensive fertility services in North America , is the clinic network of Inception Fertility ™ – a family of fertility brands that touches every part of the fertility journey, including diagnostics and treatment to financial accessibility.

Each clinic, as part of Prelude, is committed to delivering the highest level of personalized fertility care by the nation's leading reproductive endocrinologists, embryologists and practitioners by focusing on an excellence in science, medicine and the patient experience.  The growing Prelude Network has more than 90 total locations nationwide, offering a wide range of fertility services including egg freezing, IVF, genetic testing, LGBTQ+ fertility options, and egg/embryo storage, among others.

Those clinics within Prelude include Aspire Fertility Austin ( Texas ); Aspire Fertility Dallas ( Texas ); Aspire Fertility McAllen ( Texas ); Aspire Fertility San Antonio ( Texas ); Aspire Houston Fertility Institute ( Texas ); Advanced Fertility Center of Chicago ( Illinois ); Center for Reproductive Medicine ( Florida ); Indiana Fertility Institute ( Indiana ); IVFMD ( Florida ); Main Line Fertility ( Pennsylvania ); NYU Langone Fertility Center ( New York ); NYU Langone RSNY ( New York ); Pacific Centre for Reproductive Medicine ( Canada ); Pacific Fertility Center ( California ); Regional Fertility Program ( Canada ); Reproductive Biology Associates ( Georgia ); Reproductive Science Center of New Jersey ( New Jersey ); Tennessee Fertility Institute ( Tennessee ), and The Reproductive Medicine Group ( Florida ).

MEDIA CONTACT: Mia Humphreys 239-297-6592 [email protected]    

SOURCE Inception Fertility

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Cultural Remittances and Modern Fertility

We argue that migrants played a significant role in the diffusion of the demographic transition from France to the rest of Europe in the late 19th century. Employing novel data on French immigration from other European regions from 1850 to 1930, we find that higher immigration to France translated into lower fertility in the region of origin after a few decades - both in cross-region regressions for various periods, and in a panel setting with region fixed effects. These results are robust to the inclusion of a variety of controls, and across multiple specifications. We also find that immigrants who themselves became French citizens achieved lower fertility, particularly those who moved to French regions with the lowest fertility levels. We interpret these findings in terms of cultural remittances, consistently with insights from a theoretical framework where migrants act as vectors of cultural diffusion, spreading new information, social norms and preferences pertaining to modern fertility to their regions of origin.

We thank Guillaume Blanc, Guillaume Daudin and Casper Worm Hansen for excellent conference discussions. We thank seminar and conference participants at Panthéon-Assas University, the Paris School of Economics, Uppsala University, the University of Manchester, Lund University, UC Riverside, the California Center for Population Research at UCLA, Duke University, San Diego State University, Brown University, PUC-Rio, EIEF, CRETE in Milos, Universitat Autònoma de Barcelona, University of Luxembourg, Barcelona Summer Forum, Tel-Aviv University, AMSE, Bocconi, IESEG and University of Milan. We also thank Anne-Sophie Bruno, David de la Croix, Petros Milionis, Martín Fernández-Sánchez, James Fenske, Martin Fiszbein, Tomás Guanziroli, Torsten Persson, Thomas Piketty, and Katia Zhuravskaya, for useful comments. We also thank Enjie Jack Ma, Maximilian Doerfler, and Mael Astruc-Le Souder for excellent research assistance. The views expressed herein are those of the authors and do not necessarily reflect the views of the National Bureau of Economic Research.

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Global Health Research – Researcher-led

GHR Researcher-led offers researcher-led funding opportunities. This means you can apply for funding for research topics of your choice, where these have been identified in collaboration with local stakeholders.

Research must address evidence needs that are locally identified and prioritised, and must promote health equity, aligning with the aims of Sustainable Development Goal 3 .

About the Global Health Research – Researcher-led programmes

Though GHR – Researcher-led we fund a range of projects and programmes, from broad ambitious programmes of work to projects with a narrower focus.

GHR –Researcher-led offers:

• clear, regular (annual) and predictable funding opportunities to give you more time to prepare your application
• researcher-led funding opportunities. This means you can apply for funding for research topics of your choice, where these have been identified in collaboration with local stakeholders
• a tiered approach with 3 bands of funding available. This makes it easier for you to find a suitable option. This recognises the breadth or research proposals - ranging from broad, ambitious research to projects with a narrow scope. We will consider applications from experienced global health researchers and those who are new to global health research
• a flexible leadership model to help you facilitate equitable partnerships

We support equitable research partnerships between researchers and institutions in the UK and/or those in LMICs eligible to receive Official Development Assistance (ODA). Through these programmes we directly fund one lead contracting institution which can be either LMIC or UK based, who then disburses funding to all.

GHR – Researcher-led has replaced and revised our previous opportunities delivered through GHR Units  and GHR Groups .

See our latest funding opportunities

What we fund

Building on our Global Health Research operating principles, the strategic aim of GHR – Researcher-led is to support applied research. To achieve this, your research should:

• scoping studies
• needs analyses
• pilot studies
• trials, where these are part of a wider programme of research; applications which include trials must include appropriate plans for strengthening capacity in trial management in LMICs
• implementation science
• address applied health research questions which target health challenges or evidence gaps. There should be evidence that the questions are prioritised by local stakeholders and policymakers
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• be designed and implemented in ways which will inform policy and/or practice. For example, through engaging with policymakers and informing local, regional or national strategies
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• include appropriate project management and financial/administrative support
• supporting less experienced researchers to lead or jointly lead on the research proposal or on significant project components, where appropriate
• offering effective mentoring and appropriate support to enable this

Funding bands

There are 3 bands of funding based on the scale and ambition of the proposed research, the maturity of partnerships, the teams’ experience and expected capacity strengthening plans. Bands differ in their leadership requirements, but UK-based researchers must always apply in collaboration with LMIC researchers.

GHR – Researcher-led band 1

This is for more established research partnerships and experienced teams. This band is suitable for teams proposing a broad, ambitious programme of research and capacity strengthening. Where research is being undertaken by an existing partnership, it is expected that the proposed research will be a significant extension of their previous research. The research will be delivered through linked work packages typically across multiple country contexts. Funded programmes are expected to lead to significant impact on health outcomes, policy and practice, and strengthen research capacity.

GHR – Researcher-led band 2

This is for developing or less mature research partnerships with varying levels of experience proposing to undertake a significant new programme of research, extend existing research and capacity strengthening, and/or include more LMIC settings. The scope and complexity of these programmes can include multiple linked components. Alternatively, they can comprehensively address a single research theme. Funded programmes will lead to lasting impact on health outcomes, policy and practice, and strengthen research capacity.

GHR – Researcher-led band 3

This is for new research partnerships and/or less experienced teams. This band is suitable for teams proposing a research project which may be at an early or developmental stage. It may be delivered in a single country context. Funded projects will have a narrower scope than band 1 and 2 programmes. Proportionate to the amount of funds requested, the project can range from a single study to a combination of studies. Projects should offer opportunities for early to mid-career researchers to develop leadership skills and progress their own research ideas. Funded projects will have clear outcomes and defined pathways to impact on health outcomes, policy and practice.

Across all 3 bands, the scope, complexity and ambition of your proposal should be proportionate to the amount of funding you are requesting.

Regardless of your level of experience, you are eligible to apply for a band 3 award where this is appropriate to the research plans; however, where less experienced researchers apply for band 1, 2 and 3 funding we expect these applications should demonstrate how appropriate mentoring and support are in place. Mentoring for a less experienced lead researcher cannot be solely from a more-experienced co-lead.

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GHR – Researcher-led will not support applications which:

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We will consider applications in any field of applied global health research. All applications must benefit people living in one or more ODA-eligible country.

To be eligible to receive GHR Researcher-led funding, your application must demonstrate how it meets Official Development Assistance (ODA) compliance criteria.

You will need to outline:

• which country or countries on the Organisation for Economic Cooperation and Development, Development Assistance Committee (OECD DAC) list  of ODA-eligible countries will directly benefit
• how your application is relevant to the development challenges of those countries
• how the outcomes will promote the health and welfare of people in a country/ countries on the OECD DAC list

Researchers from institutions in high-income countries are not eligible to apply as Sole Lead. Where elements of your research are undertaken outside an ODA-eligible country, you must clearly state the reasons for this in your application. For example, you may need specialist expertise. If you know a country will be removed from the ODA-DAC list during the lifetime of your project, you will need to show how your research benefits ODA-eligible countries.

The GHR – Researcher-led programmes have a two-stage assessment. Stage 1 is a shortlisting outline stage. If you are successful at Stage 1, you will be invited to submit a full application at Stage 2. Feedback is provided to applicants at each stage.

Our first GHR –Researcher-led funding opened on 17 July 2024. Visit the  GHR – Researcher-led funding opportunity page for full details.  From there, you will be taken to our application system where you will need to complete and submit your application by the closing date.

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New Battery Cathode Material Could Revolutionize EV Market and Energy Storage

Sep 22, 2024 — atlanta, ga.

Zhantao Liu with the new low-cost cathode that could revolutionize lithium-ion batteries and the EV industry.      Photo by Jerry Grillo

A multi-institutional research team led by Georgia Tech’s  Hailong Chen has developed a new, low-cost cathode that could radically improve lithium-ion batteries (LIBs) — potentially transforming the electric vehicle (EV) market and large-scale energy storage systems. 

“For a long time, people have been looking for a lower-cost, more sustainable alternative to existing cathode materials. I think we’ve got one,” said Chen, an associate professor with appointments in the George W.  Woodruff School of Mechanical Engineering and the  School of Materials Science and Engineering .

The revolutionary material, iron chloride (FeCl3), costs a mere 1-2% of typical cathode materials and canstore the same amount of electricity. Cathode materials affect capacity, energy, and efficiency, playing a major role in a battery’s performance, lifespan, and affordability.

“Our cathode can be a game-changer,” said Chen, whose team describes its work in Nature Sustainability . “It would greatly improve the EV market — and the whole lithium-ion battery market.”

First commercialized by Sony in the early 1990s, LIBs sparked an explosion in personal electronics, like smartphones and tablets. The technology eventually advanced to fuel electric vehicles, providing a reliable, rechargeable, high-density energy source. But unlike personal electronics, large-scale energy users like EVs are especially sensitive to the cost of LIBs. 

Batteries are currently responsible for about 50% of an EV’s total cost, which makes these clean-energy cars more expensive than their internal combustion, greenhouse-gas-spewing cousins. The Chen team’s invention could change that.

Building a Better Battery

Compared to old-fashioned alkaline and lead-acid batteries, LIBs store more energy in a smaller package and power a device longer between charges. But LIBs contain expensive metals, including semiprecious elements like cobalt and nickel, and they have a high manufacturing cost. 

So far, only four types of cathodes have been successfully commercialized for LIBs. Chen’s would be the fifth, and it would represent a big step forward in battery technology: the development of an all-solid-state LIB.

Conventional LIBs use liquid electrolytes to transport lithium ions for storing and releasing energy. They have hard limits on how much energy can be stored, and they can leak and catch fire. But all-solid-state LIBs use solid electrolytes, dramatically boosting a battery’s efficiency and reliability and making it safer and capable of holding more energy. These batteries, still in the development and testing phase, would be a considerable improvement. 

As researchers and manufacturers across the planet race to make all-solid-state technology practical, Chen and his collaborators have developed an affordable and sustainable solution. With the FeCl3 cathode, a solid electrolyte, and a lithium metal anode, the cost of their whole battery system is 30-40% of current LIBs. 

“This could not only make EVs much cheaper than internal combustion cars, but it provides a new and promising form of large-scale energy storage, enhancing the resilience of the electrical grid,” Chen said. “In addition, our cathode would greatly improve the sustainability and supply chain stability of the EV market.”

Solid Start to New Discovery

Chen’s interest in FeCl3 as a cathode material originated with his lab’s research into solid electrolyte materials. Starting in 2019, his lab tried to make solid-state batteries using chloride-based solid electrolyteswith traditional commercial oxide-based cathodes. It didn’t go well — the cathode and electrolyte materials didn’t get along. 

The researchers thought a chloride-based cathode could provide a better pairing with the chloride electrolyte to offer better battery performance.

“We found a candidate (FeCl3) worth trying, as its crystal structure is potentially suitable for storing and transporting Li ions, and fortunately, it functioned as we expected,” said Chen.

Currently, the most popularly used cathodes in EVs are oxides and require a gigantic amount of costly nickel and cobalt, heavy elements that can be toxic and pose an environmental challenge. In contrast, the Chen team’s cathode contains only iron (Fe) and chlorine (Cl)—abundant, affordable, widely used elements found in steel and table salt.

In their initial tests, FeCl3 was found to perform as well as or better than the other, much more expensive cathodes. For example, it has a higher operational voltage than the popularly used cathode LiFePO4 (lithium iron phosphate, or LFP), which is the electrical force a battery provides when connected to a device, similar to water pressure from a garden hose. 

This technology may be less than five years from commercial viability in EVs. For now, the team will continue investigating FeCl3 and related materials, according to Chen. The work was led by Chen and postdoc Zhantao Liu (the lead author of the study). Collaborators included researchers from Georgia Tech’s Woodruff School (Ting Zhu) and the  School of Earth and Atmospheric Sciences  (Yuanzhi Tang), as well as the  Oak Ridge National Laboratory  (Jue Liu) and the  University of Houston  (Shuo Chen).

“We want to make the materials as perfect as possible in the lab and understand the underlying functioning mechanisms,” Chen said. “But we are open to opportunities to scale up the technology and push it toward commercial applications.”

CITATION: Zhantao Liu, Jue Liu, Simin Zhao, Sangni Xun, Paul Byaruhanga, Shuo Chen, Yuanzhi Tang, Ting Zhu, Hailong Chen. “Low-cost iron trichloride cathode for all-solid-state lithium-ion batteries.” Nature Sustainability .

FUNDING: National Science Foundation (Grant Nos. 1706723 and 2108688)

Hailong Chen and Zhantao Liu

Hailong Chen and Zhantao Liu present a new, low-cost cathode for all-solid-state lithium-ion batteries. Photo by Jerry Grillo

Jerry Grillo

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Selling Sunset ’s Mary Bonnet Gives Update on Her Fertility Journey

After sharing her miscarriage on selling sunset season seven, mary bonnet—who just released her book selling sunshine —spoke with e about where she and husband romain are on their fertility journey..

Mary Bonnet isn’t sure what the next chapter will be in her fertility journey .

However, the Selling Sunset star—who released her first book Selling Sunshine with HarperCollins Sept. 24—knows she and husband of six years Romain Bonnet are on the same page about figuring it out together.

“We don't know what the outcome is going to be,” Mary told E! News in an exclusive interview. “We're just kind of taking it as it as it comes. I've been super busy right now with the book and with the season and everything. So, I know nothing's going to happen if I'm stressed out and if I'm running around.”

The 44-year-old also noted she would need to undergo a procedure.

Having detailed in her book that she was diagnosed with a septate uterus (when the uterus is divided into two parts by a membrane), “I have to have surgery,” she continued, “and so I have to get that done and then have time for healing and then start the whole process. So, I just need time to do that.”

For now, Mary is taking the time she needs to figure out what’s best for her and Romain.

“We're trying to decide,” she added. “It just takes a lot of time, and we just don't know what's going to happen because I'm 44. The other times we tried to freeze embryos it wasn't successful. So we're weighing our options.”

And as Mary and Romain navigate their future, they know they can count on the love and support of Austin —the 27-year-old she had with an ex-boyfriend when she was 15—and their beloved dogs.

“We have our fur baby though, Thor . Romaine is obsessed with him,” added the real estate agent, who said goodbye to dog Niko on the most recent season of Selling Sunset and also shares dog Zelda with ex Jason Oppenheim . “So if it doesn't happen, he says he's OK. He’s got his little fur baby, and he is just beyond obsessed. We’ll be OK. What's meant to be will be.”

As Mary pens in her book, she decided to do embryo freezing in between filming seasons five and six of Selling Sunset in 2022.

“We started with 15 eggs, which is a lot, and 10 of them were the right size,” she wrote in Selling Sunshine . “Seven of those 10 were mature enough to be fertilized, and three of those seven made it through fertilization. Those three were then sent to the genetics lab to be tested and analyzed. Unfortunately, a few days later, in a very disappointing turn of events, we found out that the three eggs that had survived most of the process were abnormal. The doctor informed us that I’d need to give my body a few months to recover, and then, if we wanted, we could go through it all again.”

A few months later, Mary continued, she and Romain decided to try to conceive “the old-fashioned way” during a trip to Bali that holiday season.

“Miraculously, or it so it seemed,” she added, “two weeks after we returned from Bali, I found out that I was pregnant.”

The moment Mary and Romain first saw the positive pregnancy test in early 2023 was captured on season seven of Selling Sunset —with the show also documenting the moment they shared the news with the rest of the cast. But later that season, she suffered a pregnancy loss—eventually revealing she had a septic miscarriage and had to undergo surgery.

Mary—who details other aspects about her health in the book, including being diagnosed with a ruptured breast implant, IBS and ADHD—revealed she chose to talk about her experiences to help others feel less alone.

“When it came to my ADHD and IBS and all the things that I have opened up about, there's just this tremendous amount of support where people are like, ‘Oh my God, thank you for talking about this.’ And it helps them,” she told E!. “And so especially when I started talking about my fertility issues, I had so many people come up to me in the streets, on social media—even men would come up and they're like, ‘I can't thank you enough.’ Because their wives are going through it, they don't know what to do. But watching it has helped their wives feel better and get out of the depression and feel like they're not alone and they're able to talk about it. And so hearing all of that, it just makes it worthwhile.”

Research to use machine learning to ’reverse-engineer’ new composite materials

Professors receive nsf grant for deep-learning model that can customize microarchitecture based on specific needs.

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When creating new materials for our modern needs, materials science engineers face a basic problem: Designing it to be strong when faced with loads in one direction may lead to structural weaknesses when facing stress from a different direction.

Binghamton University Assistant Professors Mir Jalil Razavi and Dehao Liu want to develop a solution using artificial intelligence and machine learning to suggest unique types of composite materials that meet specific mechanical behavior requirements.

“When we look at materials now, we usually tune mechanical properties in one direction,” Razavi said. “For example, they can absorb the shock in ‘x’ direction, but they don’t pay attention to what will happen to the ‘y’ or ‘z’ direction. While we strengthen in one direction, maybe we’ll compromise their mechanical properties in the other directions.”

A recent $313,087 grant from the National Science Foundation will fund the development of a deep-learning model informed by the principles of physical laws that can customize the microarchitecture of composite materials.

“Imagine trying to mix two types of materials,” Liu said. “One is very solid and stiff. One is very soft, like if you mix stone and gel and then glue them together. How can you design the distribution of the stone and the gel? They can show different mechanical properties at different directions.”

Razavi and Liu will develop thousands of mechanical computational models to train deep learning algorithms in designing composite materials tailored to specific needs. They will decide which suggestions are most promising, and their collaborator, Associate Professor Yanyu Chen from the University of Louisville (Kentucky), will validate the best combinations through additive manufacturing (3D printing), X-ray imaging and stress testing.

“With this research, the goal would be that you give the material properties you are seeking in that different direction, and I inversely fabricate the material for you,” Razavi said.

The idea for the project originated from Razavi’s research on the human brain . He hopes to chart the formation of brain folds as faster-growing grey matter (the outer layer where higher-level thinking is done) grows on top of white matter (the inner layer that communicates between different gray matter areas and between the gray matter and the rest of the body).

“Because brain tissue has different fiber tracts, it shows different mechanical properties in different directions,” he said. “When we want to fully characterize brain tissue, we need multiple loading cases to analyze that.”

The Binghamton team believes this machine learning research could revolutionize materials design and enable the rapid development of new materials with tailored properties for a wide range of applications, such as designing lighter structures, effective shock absorbers and aerospace components.

“It could be used not just in advanced areas like the brain, but also everyday materials like helmets and shoes,” Liu said. “If your shoes don’t feel comfortable, you can design your own personal pair using materials with different mechanical properties.”

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Will A.I. Be a Bust? A Wall Street Skeptic Rings the Alarm.

Jim Covello, Goldman Sachs’s head of stock research, warned that building too much of what the world doesn’t need “typically ends badly.”

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By Tripp Mickle

Tripp Mickle reported this article by visiting Goldman Sachs’s office in New York and attending its tech conference in San Francisco.

As Jim Covello’s car barreled up Highway 101 from San Jose to San Francisco this month, he counted the billboards about artificial intelligence. The nearly 40 signs he passed, including one that promoted something called Writer Enterprise AI and another for Speech AI, were fresh evidence, he thought, of an economic bubble.

“Not that long ago, they were all crypto,” Mr. Covello said of the billboards. “And now they’re all A.I.”

Mr. Covello, the head of stock research at Goldman Sachs, has become Wall Street’s leading A.I. skeptic. Three months ago, he jolted markets with a research paper that challenged whether businesses would see a sufficient return on what by some estimates could be $1 trillion in A.I. spending in the coming years. He said generative artificial intelligence, which can summarize text and write software code, made so many mistakes that it was questionable whether it would ever reliably solve complex problems.

The Goldman paper landed days after a partner at Sequoia Capital, a venture firm, raised similar questions in a blog post about A.I. Their skepticism marked a turning point for A.I.-related stocks, leading to a reassessment of Wall Street’s hottest trade.

Goldman’s basket of A.I. stocks, which is managed by a separate arm of the firm and includes Nvidia, Microsoft, Apple, Alphabet, Amazon, Meta and Oracle, has declined 7 percent from its peak on July 10, as investors and business leaders debate whether A.I. can justify its staggering costs.

The pause has come early in the A.I. arms race. The tech industry has a history of spending big to deliver technology transitions, as it did during the personal computer and internet revolutions. Those build-outs spanned five years or more before there was a reckoning.

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