Actively Recruiting
Fertilo In Vitro Research Study and Trial
Led by Gameto, Inc. · Updated on 2025-12-05
500
Participants Needed
11
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Fertilo In Vitro Research Study and Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent.
- Premenopausal, age 18-35.
- Body mass index (BMI) between 21 and 40.
- Candidate for IVF according to ASRM definition (infertile for 12 months, require donor sperm, or unable to achieve pregnancy based on medical or reproductive history).
- No contraindications to oral contraceptive pills or gonadotropins.
- Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
- Anti-mullerian hormone (AMH) level of 3 ng/mL or higher within 6 months of screening or assessed at screening.
- Normal uterine cavity assessed within 12 months or at screening.
- Adequate visualization of both ovaries without significant abnormalities or major cysts within 3 months or at screening.
- No endometriosis of American Fertility Society grade 3 or 4 or endometrioma.
- At least 1 month without clomiphene citrate, GnRH agonist, or gonadotropin treatment before ovarian stimulation.
- Male partner has semen analysis within 12 months adequate for ICSI or use of donor sperm.
You will not qualify if you...
- History of recurrent pregnancy loss (more than 2 clinical pregnancies without live birth).
- Baseline prolactin levels greater than 30 ng/ml.
- Male partner requires retrograde ejaculation procedures or surgical sperm retrieval.
- Any pathology that could impair embryo implantation or pregnancy continuation.
- Use of preimplantation genetic testing during study participation.
- Use of donated oocytes, embryos, or blastocysts during this treatment cycle or from previous cycles.
- Participation in another clinical trial or investigational drug trial within the past 2 months.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
HRC Fertility
Encino, California, United States, 91436
Actively Recruiting
2
Florida Fertility Institute
Clearwater, Florida, United States, 33759
Actively Recruiting
3
IVF Florida
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
4
Shady Grove Fertility
Rockville, Maryland, United States, 20850
Actively Recruiting
5
Columbia University Fertility Center
New York, New York, United States, 10019
Actively Recruiting
6
Reach Fertility
Charlotte, North Carolina, United States, 28207
Actively Recruiting
7
Conceptions Fertility
Raleigh, North Carolina, United States, 27607
Actively Recruiting
8
Care Fertility
Bedford, Texas, United States, 76022
Actively Recruiting
9
Dallas Fort Worth Fertility Associates
Dallas, Texas, United States, 75231
Actively Recruiting
10
Shady Grove Houston
Webster, Texas, United States, 77598
Actively Recruiting
11
Utah Fertility Center
Pleasant Grove, Utah, United States, 84062
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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