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RECRUITING Phase 3 ClinicalTrials.gov

Fertilo In Vitro Research Study and Trial

Sponsor: Gameto, Inc. • ClinicalTrials.gov ID: NCT06858111

Registry updated: 2026-10-07
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Description

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.

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.

Eligibility criteria

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-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit. 8. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit. 9. 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. 10. No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma. 11. Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation. 12. 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. Exclusion Criteria: 1. History of recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth). 2. Baseline prolactin levels greater than 30 ng/ml 3. Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals. 4. Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation. 5. Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study. 6. 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. 7. Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.

Conditions

In Vitro Maturation of Oocytes

Locations

  • Women's Specialty & Fertility Center — Clovis, California, United States
  • 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
  • Aspire Fertility Dallas — Addison, Texas, United States
  • Aspire Fertility Austin — Austin, Texas, United States
  • Care Fertility — Bedford, Texas, United States
  • Dallas Fort Worth Fertility Associates — Dallas, Texas, United States
  • Pozitivf Fertility San Antonio — San Antonio, Texas, United States
  • Aspire Fertility San Antonio — San Antonio, Texas, United States
  • Shady Grove Houston — Webster, Texas, United States
  • Utah Fertility Center — Pleasant Grove, Utah, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record