
An IVF Alternative Could Make Having Babies Less Onerous
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 The study, which was carried out in Mexico and Peru, has not yet been peer-reviewed.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.

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Miami Herald
09-07-2025
- Miami Herald
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Business Wire
24-04-2025
- 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.