Latest news with #Fertilo
Business Wire
24-04-2025
- Health
- Business Wire
Gameto Announces First U.S. Clinical Site Open for Enrollment in Fertilo Study
AUSTIN, Texas--(BUSINESS WIRE)-- Gameto, a clinical-stage biotech company developing iPSC-based therapies to transform fertility care, today announced that the Reproductive Fertility Center in Corona, CA, led by , is now open for patient enrollment in Gameto's first clinical study of Fertilo in the United States. Fertilo is an investigational platform designed to reduce the burden of ovarian stimulation for women undergoing fertility treatment. By using engineered ovarian support cells to promote egg maturation outside of the body, Fertilo aims to shorten or eliminate the need for weeks of hormone injections typically required in conventional in vitro fertilization (IVF) cycles. The trial at Reproductive Fertility Center represents a significant milestone as Gameto expands Fertilo's clinical development across leading fertility centers in the U.S. In addition to this center in California, Gameto expects to open over a dozen additional clinical sites in the coming weeks as part of its U.S. Fertilo study rollout. New sites are anticipated across key states including Florida, Texas, New York, and Connecticut, with more locations to follow. 'Opening our first U.S. clinical site for our pivotal study, is an exciting step forward for Gameto and for the future of fertility care,' said Dr. Dina Radenkovic, CEO & Co-Founder, Gameto. 'We are proud to partner with Dr. Williams and his outstanding team at Reproductive Fertility Center to offer women a new investigational option aimed at making fertility treatment faster, easier, and less invasive.' The Fertilo study will evaluate the ability of engineered ovarian support cells to mature patient eggs ex vivo, with the goal of achieving fertilization and embryo development after a much shorter period of ovarian stimulation. Patients participating in the study will receive personalized monitoring and care at Reproductive Fertility Center, one of Southern California's leading fertility clinics. 'We are excited to be the first clinical site in the U.S. enrolling patients in this innovative study,' said Dr. Daniel Williams, Medical Director of Reproductive Fertility Center. 'Our mission has always been to provide patients with access to the latest advances in reproductive medicine. Fertilo has the potential to offer a safer, simpler alternative for women who want to preserve their fertility or start a family. And with the expertise of our clinical team, including Dr. James P. Lin and Dr. Susan Nasab, we are proud to contribute to advancing this important research.' Gameto recently published a preprint on medRxiv demonstrating that Fertilo can effectively promote egg maturation, leading to a higher number of viable embryos and significantly improved pregnancy success rates. In mini-stimulation (mini-stim) cycles supplemented with Fertilo, patients achieved a 44% pregnancy rate per cycle after the first embryo transfer, more than double the success rate typically observed with conventional in vitro maturation (IVM), which stands at 20%. Patients treated with Fertilo also had more viable embryos available for transfer, further enhancing their chances of conception. The company plans to open additional clinical sites in its pivotal U.S. Phase 3 clinical trial (NCT06858111) of Fertilo, a first-in-class iPSC-derived therapy. Individuals interested in joining the study can learn more at About Fertilo Fertilo is Gameto's ovarian support cell (OSC) product that matures eggs outside the body using iPSC-derived cells. By mimicking the natural ovarian environment in vitro, Fertilo enables replacement of ~80% of hormone injections and shortens IVF or egg freezing cycles from 10-14 days to just 2-3 days. This approach offers a potentially safer, less invasive alternative to traditional IVF, significantly reducing patient burden and the risk of ovarian hyperstimulation. About Gameto Gameto is a biotechnology company developing novel solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to or follow us on Twitter and Instagram @gametogen and on LinkedIn.
Yahoo
24-04-2025
- Business
- Yahoo
Gameto Announces First U.S. Clinical Site Open for Enrollment in Fertilo Study
- Reproductive Fertility Center in Corona, CA to offer novel investigational platform for fertility treatment AUSTIN, Texas, April 24, 2025--(BUSINESS WIRE)--Gameto, a clinical-stage biotech company developing iPSC-based therapies to transform fertility care, today announced that the Reproductive Fertility Center in Corona, CA, led by Dr. Daniel Williams, is now open for patient enrollment in Gameto's first clinical study of Fertilo in the United States. Fertilo is an investigational platform designed to reduce the burden of ovarian stimulation for women undergoing fertility treatment. By using engineered ovarian support cells to promote egg maturation outside of the body, Fertilo aims to shorten or eliminate the need for weeks of hormone injections typically required in conventional in vitro fertilization (IVF) cycles. The trial at Reproductive Fertility Center represents a significant milestone as Gameto expands Fertilo's clinical development across leading fertility centers in the U.S. In addition to this center in California, Gameto expects to open over a dozen additional clinical sites in the coming weeks as part of its U.S. Fertilo study rollout. New sites are anticipated across key states including Florida, Texas, New York, and Connecticut, with more locations to follow. "Opening our first U.S. clinical site for our pivotal study, is an exciting step forward for Gameto and for the future of fertility care," said Dr. Dina Radenkovic, CEO & Co-Founder, Gameto. "We are proud to partner with Dr. Williams and his outstanding team at Reproductive Fertility Center to offer women a new investigational option aimed at making fertility treatment faster, easier, and less invasive." The Fertilo study will evaluate the ability of engineered ovarian support cells to mature patient eggs ex vivo, with the goal of achieving fertilization and embryo development after a much shorter period of ovarian stimulation. Patients participating in the study will receive personalized monitoring and care at Reproductive Fertility Center, one of Southern California's leading fertility clinics. "We are excited to be the first clinical site in the U.S. enrolling patients in this innovative study," said Dr. Daniel Williams, Medical Director of Reproductive Fertility Center. "Our mission has always been to provide patients with access to the latest advances in reproductive medicine. Fertilo has the potential to offer a safer, simpler alternative for women who want to preserve their fertility or start a family. And with the expertise of our clinical team, including Dr. James P. Lin and Dr. Susan Nasab, we are proud to contribute to advancing this important research." Gameto recently published a preprint on medRxiv demonstrating that Fertilo can effectively promote egg maturation, leading to a higher number of viable embryos and significantly improved pregnancy success rates. In mini-stimulation (mini-stim) cycles supplemented with Fertilo, patients achieved a 44% pregnancy rate per cycle after the first embryo transfer, more than double the success rate typically observed with conventional in vitro maturation (IVM), which stands at 20%. Patients treated with Fertilo also had more viable embryos available for transfer, further enhancing their chances of conception. The company plans to open additional clinical sites in its pivotal U.S. Phase 3 clinical trial (NCT06858111) of Fertilo, a first-in-class iPSC-derived therapy. Individuals interested in joining the study can learn more at About FertiloFertilo is Gameto's ovarian support cell (OSC) product that matures eggs outside the body using iPSC-derived cells. By mimicking the natural ovarian environment in vitro, Fertilo enables replacement of ~80% of hormone injections and shortens IVF or egg freezing cycles from 10-14 days to just 2-3 days. This approach offers a potentially safer, less invasive alternative to traditional IVF, significantly reducing patient burden and the risk of ovarian hyperstimulation. About GametoGameto is a biotechnology company developing novel solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to or follow us on Twitter and Instagram @gametogen and on LinkedIn. View source version on Contacts InvestorKylie Jordankylie@ MediaKimberly HaKKH 917-291-5744 Sign in to access your portfolio
WIRED
07-04-2025
- Health
- WIRED
An IVF Alternative Could Make Having Babies Less Onerous
Apr 7, 2025 8:16 AM Startup Gameto has developed a technique for maturing eggs outside the body that's showing promise at helping patients get pregnant with fewer hormone treatments. Photograph:More and more people are turning to in vitro fertilization, or IVF, to have babies. The process can be arduous, requiring injections of costly hormones twice a day for two weeks to mature eggs so that they can be retrieved from the body. New York startup Gameto is aiming to ease this burden for patients by maturing eggs outside the body instead. The company's method replaces 80 percent of the hormone injections needed for traditional IVF, shortening the length of a treatment cycle to a few days. It's showing promise at generating healthy embryos and pregnancies, according to new data released by the company. Maturing eggs in a lab instead of in the ovaries isn't a new idea. In vitro maturation, or IVM, emerged in the 1990s, but the technique isn't widely used because it has lower success rates than IVF. During IVM, eggs are extracted and grown in a special concoction of nutrients and growth factors. With Gameto's approach, eggs are ripened with ovarian 'support' cells derived from stem cells. In a preprint posted online, Gameto showed that its product, dubbed Fertilo, led to higher pregnancy rates than conventional IVM. In the first part of the study, an initial 20 patients received Fertilo to evaluate the safety of the technique. In the second part, 20 more patients were randomized to receive either Fertilio or IVM. Eggs matured with Fertilo were more likely to develop normally, with a 70 percent maturation rate compared to 52 percent using standard IVM. When these eggs were then fertilized with sperm, Fertilo resulted in more viable embryos and a higher pregnancy rate—44 percent of patients in the Fertilo group got pregnant after one treatment cycle, while 20 percent who underwent IVM did. To date, the study has led to 15 ongoing pregnancies, 13 from Fertilo treatment and two from IVM. One patient in the Fertilo group became pregnant naturally after egg retrieval and was not included in the final analysis. The study, which was carried out in Mexico and Peru, has not yet been peer-reviewed. 'The idea of Fertilo is to bring a patient-centric solution, one that is truly empowering and makes it a lot easier for people to build a family,' says Dina Radenkovic, Gameto's CEO and founder. Radenkovic actually tested Gameto's technology on her own eggs—not to get pregnant, but to see how well Fertilo did at maturing them. The ovaries naturally produce one mature egg a month until menopause. In an IVF cycle, patients self-inject high doses of hormones for 10 to 14 days to spur their ovaries into producing many of them. The shots cause mood swings, headaches, bloating, and, in rare cases, a painful and potentially serious condition called ovarian hyperstimulation syndrome. In the US, stimulation meds range between $4,000 and $7,000 per treatment cycle, which can amount to a third of the total cost of IVF. And many patients need a few cycles to get pregnant. With Gameto's method, patients take an initial two to three days of hormones, then undergo egg retrieval. The eggs are incubated with ovarian support cells for about 30 hours. Gameto has developed a way to engineer these specialized reproductive cells from stem cells. 'We're able to utilize these cells to recreate the ovary outside the body,' says Christian Kramme, Gameto's chief scientific officer. By reducing the amount of drugs and time to egg retrieval, Gameto is aiming to make it easier for patients to freeze their eggs and have babies. The approach has led to one live birth in Peru, announced in December. A second woman in Peru who received Fertilo is expected to give birth in late April or early May. What patients might really want to know, though, is how Fertilo stacks up against standard IVF. That question wasn't addressed in Gameto's study, and it's hard to make a head-to-head comparison. IVF success rates vary widely depending on the patient's age and their ovarian reserve, meaning the number and quality of eggs remaining in the ovaries. Live birth rates can be as high as 50 percent for patients under 35 years old, but that number declines with age. Gameto's study included patients under the age of 37 with a high ovarian reserve, which may in part explain the success rate. David Sable, a life sciences investor and former reproductive endocrinologist, says Gameto's technique looks promising, but it's hard to draw any definitive conclusions with such a small sample size. 'The question is, are they developing a better version of an inferior process, or are they developing something that really can compete with what we're doing now with IVF?' he says. Gameto will try to answer that question in a large Phase 3 trial it just launched in the US. In that trial, the company will study Fertilo's efficacy in several hundred patients. It's unlikely that Fertilo would be better than standard IVF—which uses the body's own ovaries as the ultimate incubator—but it might not have to be for some patients to see it as a viable alternative. Radenkovic says Gameto's approach might be especially attractive for younger patients looking to freeze their eggs. Patients hoping to have a baby immediately are more willing to deal with drug side effects and multiple doctor's appointments, she reasons. But those banking their eggs as an insurance policy for the future may be less willing to undergo a disruptive procedure with a lengthy hormone regimen. Patients with polycystic ovarian syndrome, or PCOS, might also benefit from a less invasive version of IVF. People with PCOS tend to be more sensitive to IVF hormones and are at higher risk for ovarian hyperstimulation syndrome, which causes the ovaries to swell and become painful. Daniel Williams, medical director of the Reproductive Fertility Center in the Los Angeles area, says reducing the medications involved in IVF could bring costs down for patients. 'The reason you need alternatives is because cost is still a major barrier for fertility treatment,' he says. 'If you can find ways to decrease the cost, you open access to patients that may not be able to do it.' The Reproductive Fertility Center is one of Gameto's US trial sites. Fertilo has been approved for use in Australia, Japan, Argentina, Paraguay, Mexico, and Peru. Radenkovic says the company hasn't yet settled on pricing in those places, and ultimately, the final cost of the procedure will be set by fertility clinics. Gameto is expecting 20 more births this year from across Latin America and Australia as a result of Fertilo. If it's successful enough, the tech could eventually be more widely adopted. 'This could be the new and more modern way of doing fertility care,' Radenkovic says.
Yahoo
31-01-2025
- Business
- Yahoo
Gameto launches Phase III iPSC fertility trial following IND greenlight
A Phase III trial investigating a method of maturing human eggs outside of the body using induced pluripotent stem cells (iPSC) has been given the green light after the US Food and Drug Administration (FDA) granted an investigational new drug (IND) application. US-based Gameto will now launch its multi-centre US trial to establish the efficacy of its ovarian support cell (OSC) technology designed to mature eggs outside the body using iPSC technology, in a system the company argues requires 80% fewer hormonal injections than traditional in vitro fertilisation (IVF) methods. Primary endpoints in the upcoming double-blind, randomised trial will consider the safety and efficacy of viable embryos produced outside the body and improving pregnancy rate assessed at 12 weeks. Secondary endpoints will investigate embryo development alongside maternal health and live birth rates. Dubbed Fertilo, the company describes its iPSC offering as able to use young ovarian support cells to recreate the natural egg maturation process in a dish. As a result, it has the potential to reduce the duration of treatment cycles down to two- or three-days while traditional methods rely on 10-14 days of high-dose hormonal stimulation to mature eggs. Gameto's chief scientific officer Christian Kramme said: 'Gameto's technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation. 'With Fertilo, we've demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level. This milestone also highlights the power of iPSCs in regenerative medicine and our computational and cell engineering platform where we have broader applications including menopause and ovarian cancer.' Gameto is entering into a relatively competitive market in terms of infertility, with research by GlobalData estimating that infertility treatments across the seven major markets brought in $2.3bn last year, rising to $3.4bn by the end of 2030. This growth is down, in part, due to the number of individuals choosing to have children later in life. GlobalData is the parent company of Clinical Trials Arena. Approval for the company's US Phase III trial comes after the company announced the first-ever live birth carried out as a result of its ovarian support cell system, to parents at the Santa Isabel Clinic, in Lima, Peru, in December 2024. Gameto's Fertilo builds on that of Japanese researcher Shinya Yamanaka, who won the Nobel Prize for Physiology and Medicine in 2012 for his discovery of iPSC. Gameto co-founder Dina Radenkovic said: 'By overcoming the major challenges of conventional IVF such as long treatment cycles, significant side effects, and the emotional and physical strain, Fertilo provides a potentially faster, safer, and more accessible solution for families. This milestone marks a turning point in reproductive health and highlights the first application of iPSC technology in IVF and the immense potential of our technology.' Elsewhere in the world of IVF treatment, Spanish fertility biotech Oxolife has presented positive exploratory Phase II data for its non-hormonal fertility pill. "Gameto launches Phase III iPSC fertility trial following IND greenlight" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
27-01-2025
- Health
- Yahoo
A Less Brutal Alternative to IVF
After my 20th shot of hormones, I texted my boyfriend, only half kidding, 'I'm dying.' We had decided to freeze embryos, but after more than a week of drugs that made me feel like an overinflated balloon and forced me to take several secret naps a day, I no longer cared whether we froze anything. I was not doing this again. In order to maximize the number of eggs that can be harvested from the human body, most women who undergo an egg retrieval spend two weeks, give or take, injecting themselves at home with a cocktail of drugs. The medications send the reproductive system into overdrive, encouraging the maximum number of egg-containing follicles to grow and mature at once. They can also cause itchiness, nausea, fatigue, sadness, headaches, moodiness, and severe bloating as your ovaries swell to the size of juicy lemons. Some people experience ovarian hyperstimulation, which can lead in rare cases to hospitalization. Studies have found the stress of fertility treatment to be a primary reason people stop pursuing it, even if they have insurance coverage. Many people who continue with IVF feel that, if they want a child, they have no other choice. 'Right now our treatment options are pretty binary,' Pietro Bortoletto, the director of reproductive surgery and a co-director of oncofertility at Boston IVF, told me. 'Either you just put sperm inside the uterus. Or you do IVF, the full-fledged Cadillac of treatment.' But a third option is emerging, one that could reduce the cost and time that fertility patients spend at the doctor's office and mitigate the side effects. It's called in vitro maturation, or IVM. Whereas IVF relies on hormone injections to ripen a crop of eggs inside the body, IVM involves collecting immature eggs from the ovaries and maturing them in the lab. The first IVM baby was born in Korea in 1991, and since then, the method has generally yielded lower birth rates than IVF. Decades later, new scientific techniques are raising the possibility that IVM could be a viable alternative to IVF—at least for some patients—and free thousands of aspiring mothers from brutal protocols. The challenge of IVM is to figure out how to make fragile, finicky human eggs mature in a dish as well as they do within the ovaries. The handful of researchers and companies leading the push to make IVM more mainstream are taking different approaches. One Texas-based company, Gameto, uses stem cells to produce something akin to an ovary in a dish, mimicking the chemical signals an egg would receive in the body. Last month, for the first time, a baby was born who was created using Gameto's stem-cell medium, Fertilo. The fertility clinic at the University of Medicine and Pharmacy at Ho Chi Minh City, in Vietnam, uses a technique that involves first allowing the retrieved eggs to rest, then ripening them. Lavima Fertility, a company that spun out of research at the Free University of Brussels, is working on commercializing that technique. [Read: They were made without eggs or sperm. Are they human?] For now, these new treatments aren't commercially available in the United States. The Food and Drug Administration hasn't historically weighed in on the media that human embryos grow in, but it asked Gameto to seek approval to market Fertilo. Gameto is now preparing for Phase 3 clinical trials. Lavima could face similar hurdles. Older IVM methods are available in the U.S., but not widely used. Meanwhile, more than a dozen women in countries where Fertilo has been cleared for use, which include Australia, Mexico, Peru, and Argentina, are carrying Fertilo-assisted pregnancies, according to the company. Compared with IVF, IVM is far more gentle. Harvesting immature follicles requires only one or two days of hormonal injections, or skips the process altogether. Reducing the hormone doses necessarily means fewer side effects and cases of ovarian hyperstimulation syndrome. (It may also curtail any possible long-term health effects of repeated exposure to these hormones, which have not been well studied.) Skipping or reducing the drugs can also save women thousands of dollars and many visits to a provider for blood work and monitoring. For women who live far from fertility clinics, or can't commit to so many visits for other reasons, this protocol could make the difference between undergoing treatment and not, Bortoletto said. Historically, IVM has generated fewer mature eggs and embryos compared with IVF. The stats are improving, but even if IVM maintains an overall lower success rate than IVF, it still could be the better option for several groups of patients. Egg donors, many of whom undergo multiple retrieval cycles, could be good candidates. So could hyper-responders—patients whose ovaries naturally develop more follicles each month, thanks to their young age or conditions such as PCOS. IVM clinicians could gather enough eggs from hyper-responders that even if a smaller number mature in the lab than might have in the ovaries, a patient would still have a good chance of pregnancy. These patients are also at the highest risk for uncomfortable or dangerous IVF side effects. IVM could be a safer choice, and an effective one. In a 2021 committee opinion, the American Society for Reproductive Medicine concluded that IVM reduced the burden of fertility treatment for these groups of patients. Some studies of hyper-responders have found a live birth rate of 40 percent or higher per IVM cycle, a number on par with that of IVF. Many women seek IVF because they are approaching their 40s and have few eggs left; they will likely never be good IVM candidates. But IVM might work just fine for patients with blocked fallopian tubes, single and LGBTQ people, and young women who want to freeze their eggs. It could also be useful to cancer patients, many of whom don't have time to undergo a lengthy IVF cycle before beginning cancer treatment that threatens their fertility. The University of Medicine and Pharmacy in Vietnam primarily offers IVM to women with PCOS, women who appear to have a significant reserve of eggs, and women with a condition that mutes their response to hormonal stimulation. Lan Vuong, who heads the department of obstetrics and gynecology, told me the live-birth rate with IVM there is about 35 percent. IVM could go far in helping to reduce the physical and emotional toll that fertility treatment takes on women at a time when more people than ever are seeking it out. In some ways, IVF's burden on women has increased: In an effort to improve birth rates, new drugs, with their attendant side effects, have been added to the standard protocols in the decades since 1978, when the first IVF baby was born. Beyond IVM, some companies are exploring new ways to reduce pain points, for instance by replacing needle injections with oral medications, some of which aim to have gentler side-effect profiles, or by having patients monitor a cycle at home instead of schlepping to the doctor every other day. Dina Radenkovic, the CEO of Gameto, told me that, within the fertility industry, there is a 'growing recognition that fertility treatments must be not only effective but also more humane.' [Read: Aspiring parents have a new DNA test to obsess over] Knowing all this, I can't help imagining how my own experience could have been different. My doctor eventually told me that part of the reason my cycle was so painful was that I was a hyper-responder, even at the advanced age of 37. If a gentler option had been available, I would have been a prime candidate. Article originally published at The Atlantic
