Austin, Texas — Gameto, a clinical-stage biotechnology company focused on transforming fertility care with cell-based therapies, has opened its first U.S. clinical trial site for its investigational fertility treatment platform, Fertilo. The Reproductive Fertility Center in Corona, California, led by Dr. Daniel Williams, is now enrolling patients for Gameto’s study, marking a key milestone in the company’s clinical development efforts.
Fertilo is designed to ease the physical and emotional burden of ovarian stimulation in women undergoing fertility treatments such as in vitro fertilization (IVF). The platform uses engineered ovarian support cells to promote egg maturation outside the body, with the goal of reducing or eliminating the need for the extended hormone injections that are typically part of conventional IVF cycles.
The California site is the first of more than a dozen clinical centers Gameto plans to open across the United States in the coming weeks. Additional trial sites are expected in major states including Florida, Texas, New York, and Connecticut, with further expansion anticipated.
“Opening our first U.S. clinical site for this pivotal study is an exciting step forward for Gameto and for the future of fertility care,” said Dr. Dina Radenkovic, CEO and co-founder of Gameto. “We are proud to collaborate with Dr. Williams and his exceptional team at Reproductive Fertility Center to offer women a novel investigational option aimed at making fertility treatments faster, easier, and less invasive.”
The Fertilo study will assess the platform’s ability to mature patient eggs outside the body, with the aim of achieving successful fertilization and embryo development after a shorter period of ovarian stimulation. Participants in the trial will receive personalized monitoring and care from the clinical team at Reproductive Fertility Center, a leading fertility clinic in Southern California.
“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 at 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 looking to preserve their fertility or start a family. 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.”
Gameto recently published preclinical data on medRxiv highlighting the promise of Fertilo. In mini-stimulation cycles supplemented with the platform, patients achieved a 44% pregnancy rate per cycle following the first embryo transfer—more than double the 20% success rate typically seen with conventional in vitro maturation (IVM) techniques. Patients treated with Fertilo also had a greater number of viable embryos available for transfer, improving their chances of conception.
The Fertilo study represents a significant step toward reshaping fertility treatments and offering women new options that reduce the demands and risks associated with traditional IVF protocols.
