Gameto, a clinical-stage biotech company developing innovative iPSC-based therapies for fertility care, has announced encouraging results from a recent study on its lead product, Fertilo. The trial, which involved 40 patients, demonstrated that Fertilo, a treatment using ovarian support cells (OSCs) derived from human-induced pluripotent stem cells (iPSCs), significantly improves in vitro maturation (IVM) outcomes.
The positive findings, published as a preprint in medRxiv, show that Fertilo boosts egg maturation, embryo formation, and clinical pregnancy rates when compared to traditional fertility treatments. The data suggest that the use of Fertilo could lead to better chances of successful pregnancies for women undergoing assisted reproduction.
The study was conducted in two phases. The first phase involved 20 patients who received Fertilo in a multi-center observational trial. This phase focused on gathering safety data and identifying success metrics. In the second phase, another 20 patients were randomly assigned to receive either Fertilo or standard IVM media during their egg retrieval process. This design allowed for a direct comparison of the outcomes between the two groups.
The results revealed that eggs matured with Fertilo were more likely to develop properly, achieving a 70% maturation rate compared to 52% for those treated with standard IVM. These matured eggs also had a higher chance of being fertilized and producing blastocysts, the early-stage embryos that are critical for successful implantation. Notably, the rate of producing euploid blastocyst embryos with the correct number of chromosomes and a higher likelihood of resulting in a healthy pregnancy was 10% per egg with Fertilo, versus just 2% with conventional IVM.
These improvements led to significantly better clinical outcomes. Fertilo-supplemented cycles saw a 44% pregnancy rate per cycle after the first embryo transfer, more than double the 20% rate achieved with standard IVM. Additionally, patients who received Fertilo had more embryos available for transfer, further increasing their chances of pregnancy success. In the comparative evaluation, 8 out of 10 Fertilo-treated patients had at least one viable, euploid embryo for implantation, compared to only 3 out of 10 in the control group.
Dr. Dina Radenkovic, CEO and Co-Founder of Gameto, praised the results, stating, “Fertilo represents a new era in family building—one that is faster, safer, and truly transformative. It provides a better option for women, same-sex couples, and anyone planning to start or expand their family.”
Dr. Christian Kramme, Chief Scientific Officer at Gameto, also highlighted the significance of the results. “These findings validate the potential of iPSC-derived products to revolutionize reproductive medicine. Fertilo demonstrated superior egg maturation, fertilization, and euploid embryo rates, leading to real-world pregnancies and live births.”
Gameto plans to expand access to Fertilo through its upcoming pivotal study in the U.S. and globally, hoping to bring this groundbreaking treatment to more families.
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