Gameto, a clinical-stage biotechnology company specializing in women’s health, has opened its first U.S. clinical site for the pivotal Phase 3 trial of Fertilo, an innovative fertility treatment designed to significantly reduce hormone injections for patients undergoing in vitro fertilization (IVF) or egg freezing. The clinical site, located at the Reproductive Fertility Center in Corona, California, is now enrolling patients to evaluate the safety and efficacy of Fertilo, which uses engineered ovarian support cells derived from induced pluripotent stem cells (iPSCs) to mature eggs outside the body.
This technology aims to shorten treatment cycles from the traditional 10–14 days to just 2–3 days, while reducing hormone injections by approximately 80%, offering a less invasive and more comfortable fertility preservation option. The study will assess key outcomes such as embryo development and pregnancy rates, with plans to expand to multiple U.S. sites including Florida, Texas, New York, and Connecticut. This milestone follows the FDA’s clearance of the Fertilo investigational new drug application and the world’s first live birth using this technology in December.
“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.”
Fertilo seeks to avoid about 80% of the hormone injections usually needed in traditional IVF cycles by simulating the natural ovarian environment in vitro. This method may provide a less invasive substitute that lowers the possibility of ovarian hyperstimulation syndrome, a possible side effect of conventional stimulation regimens.
As part of its U.S. trial rollout, Gameto intends to create over a dozen clinical sites in the upcoming weeks, with the California facility being the first. For its Phase 3 clinical trial (NCT06858111), the company plans to open more locations in Florida, Texas, New York, and Connecticut.
“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.”
According to Gameto’s recently released early data, Fertilo showed encouraging outcomes in mini-stimulation cycles. Following the initial embryo transfer, patients had a 44% pregnancy rate per cycle, which is more than twice the 20% success rate usually seen with traditional in vitro maturation (IVM). Additionally, more viable embryos that could be transferred were apparently produced by the method.
Gameto’s strategy suggests a possible change in the way reproductive treatments are administered. The approach attempts to solve one of the most onerous features of fertility treatments—the protracted course of daily hormone injections—by concentrating on growing eggs outside the body with supportive cells that replicate the ovarian environment.
