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 The study, which was carried out in Mexico and Peru, has not yet been peer-reviewed.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 too early to know whether 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.
Update: 4/7/2025, 4:45 PM EDT: Wired has clarified how it describes Fertilo in relation to standard IVF.
