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RECRUITING
NCT06858111
PHASE3

Fertilo In Vitro Research Study and Trial

Sponsor: Gameto, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2025-04-17

Completion Date

2028-01

Last Updated

2025-12-05

Healthy Volunteers

Yes

Interventions

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.

Locations (11)

HRC Fertility

Encino, California, United States

Florida Fertility Institute

Clearwater, Florida, United States

IVF Florida

Pembroke Pines, Florida, United States

Shady Grove Fertility

Rockville, Maryland, United States

Columbia University Fertility Center

New York, New York, United States

Reach Fertility

Charlotte, North Carolina, United States

Conceptions Fertility

Raleigh, North Carolina, United States

Care Fertility

Bedford, Texas, United States

Dallas Fort Worth Fertility Associates

Dallas, Texas, United States

Shady Grove Houston

Webster, Texas, United States

Utah Fertility Center

Pleasant Grove, Utah, United States