Gameto, Inc.
The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation. Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm. * Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours. * Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.
Inclusion Criteria: 1. Written informed consent. 2. Premenopausal, Age 18-35. 3. Body mass index (BMI) 21-40. 4. Candidate for IVF according to the ASRM definition (infertile for ≥12 months, require the use of donor sperm, or the inability to achieve a successful pregnancy based on a patient's medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors). 5. No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins. 6. Plan to use embryos for transfer within 2 months of blastocyst cryopreservation. 7. Anti-…
Fertilo is an engineered line of ovarian support cells that aid egg maturation.
MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.