Chief Scientific Officer Gameto Inc. New York City, New York, United States
Abstract: Despite the popularity of in vitro fertilization (IVF), several barriers to accessibility remain, including cost, time, and the amount of hormone injection required. In vitro maturation (IVM), in which the patient undergoes an abbreviated stimulation regimen, reduces the burden associated with IVF. However, the current standard of care treatment for IVM has limited efficacy with low rates of oocyte maturation, embryo formation, and pregnancy. Recently, we demonstrated the clinical development of Fertilo, which is a novel ex vivo applied cell therapy product designed to support the IVM of oocytes via co-culture with current Good Manufacturing Practice (cGMP) compliant human induced pluripotent stem cell (hiPSC)-derived ovarian support cells (OSCs). To evaluate the clinical efficacy of Fertilo, a two phase study was conducted. In the first phase, 50 patients underwent 5 different minimal stimulation regimens prior to IVM with Fertilo to identify the optimal regimen. In the second phase, 20 patients underwent the preferred minimal stimulation regimen and retrieved oocytes were subjected to IVM in either Fertilo or MediCult IVM control conditions. In phase I, stimulation with CC and rFSH + trigger led to the most favorable outcomes, with an 11% euploid HQ blastocyst formation rate per COC and a 33% ongoing pregnancy rate per cycle. In phase II, Fertilo significantly improved the euploid HQ blastocyst formation rate (p=0.0135) and the transferable blastocyst formation rate (p=0.0040) compared to MediCult IVM. Of note, embryo transfers are ongoing in both phases and no adverse events have been reported for any patients. In phase I of this study, the first live birth of a healthy singleton female following a Fertilo treatment cycle occurred at 38.5 weeks without complication, providing evidence of the efficacy and safety of Fertilo and the first ever report of a live birth from a hiPSC-derived cell therapy application in IVF. These results demonstrate that the hiPSC-derived cell therapy Fertilo applied with a minimal stimulation regimen including CC and rFSH is an efficacious and safe option to improve IVM outcomes and broadens the population of individuals suitable to undergo IVF.
