Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2025-04-17
2028-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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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.
Fertilo
Fertilo is an engineered line of ovarian support cells that aid egg maturation.
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.
Medicult IVM
MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.
Interventions
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Fertilo
Fertilo is an engineered line of ovarian support cells that aid egg maturation.
Medicult IVM
MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
35 Years
FEMALE
Yes
Sponsors
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Gameto, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Care Fertility
Bedford, Texas, United States
Dallas Fort Worth Fertility Associates
Dallas, Texas, United States
Shady Grove Houston
Webster, Texas, United States
Utah Fertility Center
Pleasant Grove, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GAM-01
Identifier Type: -
Identifier Source: org_study_id
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