An IVF Alternative Could Make Having Babies Less Onerous

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.