Gameto, a biotechnology company dedicated to advancing women’s healthcare, has unveiled promising findings from a recent study evaluating the impact of minimal controlled ovarian stimulation (COS) combined with their investigational in vitro maturation (IVM) solution, Fertilo, on patients’ egg retrieval experiences compared to conventional stimulation protocols. The study revealed that women undergoing minimal hormonal stimulation with Fertilo reported fewer side effects, less pain post-retrieval, and higher satisfaction rates with the abbreviated stimulation procedure when compared to conventional in vitro fertilization (IVF) methods.
“This study is significant because female patients’ pain, morbidity, and inconvenience are frequently minimized and neglected in the healthcare setting, and often more so for women pursuing fertility treatments and egg or embryo freezing,” said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. “We are encouraged by these and previously published efficacy data which demonstrate that combining minimal hormonal stimulation with our investigational in vitro maturation solution may help women navigating fertility treatments avoid many of the common side effects associated with the conventional IVF hormone protocol. We care about the efficacy but also about the experience.”
Fertilo, Gameto’s lead investigational program, leverages induced pluripotent stem cells (iPSC) to mature eggs outside the body, aiming to streamline fertility treatments and make them more convenient and safer for patients. The solution, already cleared for commercialization in Australia and select markets in Latin America, holds the promise of revolutionizing fertility care by offering a more patient-centric approach.
The retrospective survey study compared outcomes between minimal stimulation OSC-IVM cycles and conventional COS protocols. Results showed significant reductions in reported side effects and pain levels among patients undergoing minimal stimulation OSC-IVM cycles. Notably, severe pain was reported by only 7.69% of participants in the minimal stimulation OSC-IVM cohort, compared to 38.46% in the conventional COS group.
Furthermore, the study revealed that minimal stimulation OSC-IVM cycles led to a considerable decrease in ovarian hyperstimulation syndrome (OHSS) incidence—a common complication associated with conventional COS. While approximately one-third of patients undergoing conventional COS experienced OHSS, none of the participants in the minimal stimulation OSC-IVM group developed the syndrome.
The study’s findings underscore the potential of minimal stimulation OSC-IVM cycles to offer a more comfortable and safer alternative to conventional IVF protocols. With 92% of patients expressing a preference for minimal stimulation OSC-IVM cycles over conventional methods, Gameto’s approach shows promise in reshaping the landscape of fertility treatments.
Gameto is actively preparing to meet FDA requirements for Phase 3 trial initiation, further advancing its commitment to redefining women’s healthcare.