Evaluating Fertilo for In Vitro Maturation of Oocytes

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

This study is testing if a new treatment called Fertilo can help women aged 18-35 have more successful pregnancies during in vitro fertilization compared to a standard treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Gameto, Inc. (industry)
• Locations: 11 sites (Encino, California and 10 other locations)
• Trial ID: NCT06858111 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of Fertilo compared to Medicult IVM for the in vitro maturation of oocytes in women aged 18-35. Participants will be randomly assigned to receive either Fertilo or Medicult IVM, with the primary outcome being the number of ongoing pregnancies at 12 weeks gestation. The study will involve culturing cumulus oocyte complexes for 30 hours in each treatment arm. This phase 3 trial seeks to determine if Fertilo offers a superior option for patients undergoing in vitro fertilization.

Who should consider this trial

Good fit: Ideal candidates are premenopausal women aged 18-35 with a BMI between 21-40 who are candidates for IVF.

Not a fit: Patients who do not meet the eligibility criteria or have contraindications to the use of oral contraceptive pills or gonadotropins may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for women undergoing in vitro fertilization.

How similar studies have performed: Other studies have explored in vitro maturation techniques, but the specific use of Fertilo in this context is novel.

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.

Where this trial is running

Encino, California and 10 other locations

• HRC Fertility — Encino, California, United States (RECRUITING)
• Florida Fertility Institute — Clearwater, Florida, United States (RECRUITING)
• IVF Florida — Pembroke Pines, Florida, United States (RECRUITING)
• Shady Grove Fertility — Rockville, Maryland, United States (RECRUITING)
• Columbia University Fertility Center — New York, New York, United States (RECRUITING)
• Reach Fertility — Charlotte, North Carolina, United States (RECRUITING)
• Conceptions Fertility — Raleigh, North Carolina, United States (RECRUITING)
• Care Fertility — Bedford, Texas, United States (RECRUITING)
• Dallas Fort Worth Fertility Associates — Dallas, Texas, United States (RECRUITING)
• Shady Grove Houston — Webster, Texas, United States (RECRUITING)
• Utah Fertility Center — Pleasant Grove, Utah, United States (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials

Conditions: In Vitro Maturation of Oocytes, IVF, IVM, In Vitro Fertilization, Fertilo, Gameto, infertility, fertility