Fertilo In Vitro Research Study and Trial

Conditions

• In Vitro Maturation of Oocytes

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 35 Years

Healthy Volunteers

Accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 17, 2025

Status verified

Jun 2026

Primary completion

May 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Fertilo
  Immature cumulus-oocyte complexes (COCs) are oocytes surrounded by cumulus cells that have not yet matured. The COCs are cultured in Fertilo coculture condition then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose.
• Active Comparator: Medicult IVM®
  Immature COCs are cultured in the standard IVM system MediCult IVM® then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose.

Primary Outcome Measure

Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures. [ Time Frame: 12 weeks gestation ]

Central Contacts

• Clinical Trials
  512-535-1164
  [email protected]

Locations (13)

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