Fertilo In Vitro Research Study and Trial

NCT06858111 | Recruiting Phase 3 FDA Drug

• 1 other identifier: GAM-01
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 13

Brief 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

Keywords

IVF; IVM; In Vitro Fertilization; Fertilo; Gameto; infertility; fertility

Outcome Measures

Primary Outcomes (1)

• Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.

  Cumulative ongoing pregnancy from cycles initiated within 6 months post-randomization. The primary endpoint of ongoing pregnancy is assessed at 12 weeks gestation or later. Cumulative ongoing pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a detectable fetal heartbeat, considered normal and healthy, are considered as having achieved an ongoing pregnancy. "Normal" will be determined as expected for the gestational age ranging from 110 bpm to 180 bpm and measured via ultrasound. Ongoing pregnancy is recorded as either a Yes or No for normal fetal heart rate present for each of the Subject's transfer cycles. Subjects without an ongoing pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., a live birth). Cumulative ongoing pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves an ongoing pregnancy, or a No otherwise.

  12 weeks gestation

Secondary Outcomes (8)

• Metaphase II (MII) Formation

  30 hours post-oocyte retrieval

• Fertilization Rate

  16-18 hours post-ICSI

• Embryo cleavage rate

  Day 3 post-ICSI

• High quality blastocyst formation rate.

  Day 5, 6, and 7 post-ICSI

• High quality vitrified blastocyst rate.

  Day 5, 6, and 7 post-ICSI

Study Arms (2)

Fertilo

EXPERIMENTAL

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.

Biological: Fertilo

Medicult IVM®

ACTIVE COMPARATOR

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.

Device: Medicult IVM

Interventions

Fertilo BIOLOGICAL

Fertilo is an engineered line of ovarian support cells that aid egg maturation.

Fertilo

Medicult IVM DEVICE

MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.

Medicult IVM®

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Cisgender females, non-binary females of childbearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent.
• Premenopausal, Age 18-35.
• Body mass index (BMI) 21-40.
• 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).
• No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
• Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
• Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit.
• Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit.
• Having adequate visualization of both ovaries, without evidence of significant abnormality/pathology or major cyst documented by transvaginal ultrasound within 3 months of screening or assessed during screening period.
• No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma.
• Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation.
• Have a male partner with semen analysis within the past 12 months prior to randomization considered adequate to proceed with intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If this criterion is not met, the subject can only be entered if donor sperm will be used.

You may not qualify if:

• History of recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
• Baseline prolactin levels greater than 30 ng/ml
• Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
• Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
• Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
• Use of donated oocytes, embryos or blastocysts for this treatment cycle while participating in the study or use of oocytes, embryos, or blastocysts from a previous treatment cycle.
• Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.

Sponsors & Collaborators

• Gameto, Inc.: lead

Study Sites (13)

Women's Specialty & Fertility Center

Clovis, California, 93611, United States

RECRUITING

HRC Fertility

Encino, California, 91436, United States

RECRUITING

Florida Fertility Institute

Clearwater, Florida, 33759, United States

RECRUITING

IVF Florida

Pembroke Pines, Florida, 33026, United States

RECRUITING

Shady Grove Fertility

Rockville, Maryland, 20850, United States

RECRUITING

Columbia University Fertility Center

New York, New York, 10019, United States

RECRUITING

Reach Fertility

Charlotte, North Carolina, 28207, United States

RECRUITING

Conceptions Fertility

Raleigh, North Carolina, 27607, United States

RECRUITING

Care Fertility

Bedford, Texas, 76022, United States

RECRUITING

Dallas Fort Worth Fertility Associates

Dallas, Texas, 75231, United States

RECRUITING

Aspire Fertility San Antonio

San Antonio, Texas, 78528, United States

RECRUITING

Shady Grove Houston

Webster, Texas, 77598, United States

RECRUITING

Utah Fertility Center

Pleasant Grove, Utah, 84062, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Clinical Trials

CONTACT

512-535-1164; clinicaltrials@gametogen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Requestord will need to contact clinicaltrials@gametogen.com and sign a data access agreement.

Locations

US (13)