NCT06858111

Fertilo In Vitro Research Study and Trial

Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Gameto, Inc. · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• In Vitro Maturation of Oocytes

Interventions

Type	Name	Description
BIOLOGICAL	Fertilo	Fertilo is an engineered line of ovarian support cells that aid egg maturation.
DEVICE	Medicult IVM	MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.

Timeline

• Start date: 2025-04-17
• Primary completion: 2027-05-01
• Completion: 2028-01-01
• First posted: 2025-03-05
• Last updated: 2025-12-05

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study