In vitro fertilization (IVF) has become a go-to option for many people trying to conceive, but the process is often grueling. It typically requires patients to inject expensive hormones twice daily for two weeks to help mature eggs before they are retrieved. However, New York-based startup Gameto is aiming to ease this burden by maturing eggs outside the body, reducing the need for hormone injections and shortening treatment cycles to just a few days.
Gameto’s innovative method replaces about 80% of the hormone injections required for traditional IVF. The company’s approach has already shown promising results, with higher pregnancy rates and healthier embryos, based on recent data shared by the company.
Egg maturation outside the body is not a new concept. In vitro maturation (IVM), a technique developed in the 1990s, involves extracting eggs and growing them in a special nutrient solution. However, IVM hasn’t gained widespread use due to lower success rates compared to IVF. Gameto’s technique uses ovarian support cells derived from stem cells to ripen eggs in a laboratory, which has led to better outcomes.
A recent study, posted as a preprint online, shows that Gameto’s method, known as Fertilo, resulted in higher pregnancy rates than conventional IVM. The study, conducted in Mexico and Peru, involved two parts. In the first phase, 20 patients received Fertilo to evaluate its safety. In the second phase, 20 more patients were randomly assigned to receive either Fertilo or traditional IVM. The results were promising: eggs matured using Fertilo had a 70% maturation rate, compared to just 52% with standard IVM.
Moreover, when the eggs were fertilized, Fertilo led to more viable embryos and a higher pregnancy rate. Forty-four percent of patients who used Fertilo became pregnant after one treatment cycle, while only 20% of IVM patients did. The study resulted in 15 ongoing pregnancies, 13 from Fertilo and two from IVM. One patient in the Fertilo group became pregnant naturally after egg retrieval, but was excluded from the analysis. Although the study has not been peer-reviewed, the results are promising.
Dina Radenkovic, Gameto’s CEO and founder, emphasized that the goal of Fertilo is to provide a patient-centered solution that simplifies the family-building process. In fact, Radenkovic tested the technology herself, using her own eggs to see how well Fertilo could mature them.
Typically, women’s ovaries produce one mature egg per month until menopause. During an IVF cycle, patients must inject high doses of hormones for 10 to 14 days to stimulate the ovaries to produce more eggs. This hormone treatment can cause mood swings, bloating, and, in rare cases, ovarian hyperstimulation syndrome, a painful condition. Hormone medications alone can cost $4,000 to $7,000 per treatment cycle, making up a significant portion of the overall IVF cost.
Gameto’s method reduces the hormone regimen to just two to three days of treatment before egg retrieval. The eggs are then incubated with ovarian support cells for about 30 hours, a process made possible by the company’s ability to engineer specialized reproductive cells from stem cells. This reduces both the amount of medication required and the time needed for egg retrieval.
By minimizing the use of hormones and shortening the treatment cycle, Gameto hopes to make egg freezing and IVF more accessible to patients. In December, the company announced the first live birth from a patient in Peru, with another expected in late April or early May.
However, it’s still unclear how Fertilo compares to standard IVF, which uses the ovaries as the natural incubator for egg development. Success rates for IVF vary depending on factors like age and ovarian reserve. For patients under 35, live birth rates can be as high as 50%, but this number declines with age. Gameto’s study focused on patients under 37 with high ovarian reserves, which may have contributed to the relatively high success rates.
David Sable, a life sciences investor and former reproductive endocrinologist, cautioned that while Gameto’s technique shows potential, it’s hard to make definitive conclusions based on the small sample size. “The question is, are they improving an inferior process, or is this truly a competitive alternative to IVF?” he asked.
To answer this, Gameto is launching a Phase 3 trial in the U.S., aiming to test the efficacy of Fertilo in several hundred patients.
While it may take time to determine if Fertilo can outperform traditional IVF, Radenkovic believes it could be an attractive alternative for younger patients looking to freeze their eggs. Those trying to conceive immediately might be more willing to endure the side effects of hormone treatments and multiple doctors’ visits. In contrast, patients freezing eggs for future use may prefer a less invasive method.
Fertilo could also benefit patients with polycystic ovarian syndrome (PCOS), who are more sensitive to IVF hormones and at higher risk for ovarian hyperstimulation syndrome. By reducing the hormonal burden, Gameto’s method may offer a safer and more cost-effective option for these patients.
Daniel Williams, medical director of the Reproductive Fertility Center in Los Angeles, pointed out that reducing medication use could lower costs for patients, making fertility treatments more accessible. “Cost is still a major barrier for many,” he said.
Gameto’s method has already been approved for use in countries including Australia, Japan, Argentina, Paraguay, Mexico, and Peru, although the final cost will depend on fertility clinics. The company is expecting 20 more births this year from Fertilo patients in Latin America and Australia.
If Fertilo proves successful, it could reshape the future of fertility treatments. “This could be the new, more modern way of doing fertility care,” said Radenkovic.
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