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RecruitingPhase 3NCT06858111

Fertilo In Vitro Research Study and Trial

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Trial Parameters

ConditionIn Vitro Maturation of Oocytes
SponsorGameto, Inc.
Study TypeINTERVENTIONAL
PhasePhase 3
Enrollment500
SexFEMALE
Min Age18 Years
Max Age35 Years
Start Date2025-04-17
Completion2027-05
Interventions
FertiloMedicult IVM

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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.

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 docum

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