Gameto has opened its first U.S. clinical site for patient enrollment in its Fertilo study, marking a significant step in the company’s efforts to transform fertility treatments. The Reproductive Fertility Center in Corona, California, led by Dr. Daniel Williams, is now accepting patients for the clinical trial.
Fertilo is an investigational platform designed to reduce the burden of ovarian stimulation during fertility treatments. The technology uses engineered ovarian support cells (OSCs) derived from induced pluripotent stem cells (iPSCs) to mature eggs outside the body, potentially shortening IVF and egg freezing cycles from the conventional 10-14 days to just 2-3 days.
“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.”
By mimicking the natural ovarian environment in vitro, Fertilo aims to eliminate approximately 80% of hormone injections typically required in conventional IVF cycles. This approach could offer a less invasive alternative that reduces the risk of ovarian hyperstimulation syndrome, a potential complication of traditional stimulation protocols.
The California site represents the first of more than a dozen clinical locations Gameto plans to open in the coming weeks as part of its U.S. study rollout. The company anticipates opening additional sites across Florida, Texas, New York, and Connecticut for its Phase 3 clinical trial (NCT06858111).
“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.”
In recently published preliminary data, Gameto reported that Fertilo demonstrated promising results in mini-stimulation cycles. Patients achieved a 44% pregnancy rate per cycle after the first embryo transfer—more than double the 20% success rate typically observed with conventional in vitro maturation (IVM). The technology also reportedly produced more viable embryos available for transfer.
Gameto’s approach represents a potential shift in fertility treatment protocols. By focusing on maturing eggs outside the body with supporting cells that mimic the ovarian environment, the technology aims to address one of the most burdensome aspects of fertility treatments—the lengthy period of daily hormone injections.
