Background: 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 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).
Objective and Methods: To evaluate the clinical efficacy of Fertilo, a two phase study was conducted. In the first phase, different minimal stimulation regimens were evaluated prior to IVM with Fertilo, and CC + rFSH + trigger led to the most favorable outcomes, with an 11% HQ blastocyst formation rate per COC and a 33% ongoing pregnancy rate per cycle. In the second phase, 20 patients underwent CC + rFSH + trigger minimal stimulation and retrieved oocytes were subjected to IVM in either Fertilo or MediCult IVM control conditions.
Results: Fertilo significantly improved the 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 on 12/09/2024 at 38.5 weeks without complication, providing evidence of the efficacy and safety of Fertilo. These results demonstrate that 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.
Ethics approval: Study Protocol Fertilo
P1, approved by the ethics committee of the Universidad Peruana Cayetano
Heredia (CIEI-FMH-USMP, FWA No. 00015320, IRB No. 00003251).
