Actively Recruiting
Phase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)
Led by Gameto, Inc. · Updated on 2026-06-04
500
Participants Needed
13
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Fertilo compared to Medicult IVM for in vitro maturation (IVM) of eggs in women aged 18 to 35. The study aims to determine if Fertilo leads to more ongoing pregnancies at 12 weeks gestation than the currently approved Medicult IVM system. This is a phase III randomized control trial sponsored by Gameto, Inc.
CONDITIONS
Brief Title
Fertilo In Vitro Research Study and Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent is required.
- Female participants aged 18 to 35 years who are premenopausal.
- Body mass index (BMI) between 21 and 40.
- Must be a candidate for IVF as defined by infertility for 12 months or more, need for donor sperm, or difficulty achieving pregnancy based on medical history.
- No contraindications to the use of oral contraceptive pills or gonadotropins.
- Embryo use planned within 2 months after blastocyst freezing.
- Anti-mullerian hormone (AMH) level of 3 ng/mL or higher within 6 months before screening or assessed at screening.
- Normal uterine cavity confirmed by hysteroscopy, hysterosalpingography, or sonohysterography within 12 months before screening or assessed at screening.
- Adequate visualization of both ovaries without major abnormalities or cysts confirmed by transvaginal ultrasound within 3 months before screening or assessed during screening.
- No severe endometriosis (American Fertility Society grade 3 or 4) or presence of endometrioma.
- At least 1 month without treatment using clomiphene citrate, GnRH agonist, or gonadotropins before ovarian stimulation starts.
- Male partner must have a semen analysis within 12 months before randomization suitable for intracytoplasmic sperm injection (ICSI), or donor sperm will be used.
You will not qualify if you...
- History of recurrent pregnancy loss defined as more than 2 clinical pregnancies without a live birth.
- Baseline prolactin levels above 30 ng/ml.
- Male partner requiring retrograde ejaculation procedures or surgical sperm retrieval.
- Any medical condition judged to impair embryo implantation or continuation of pregnancy.
- Use of preimplantation genetic testing (PGT) during the study.
- Use of donated oocytes, embryos, or blastocysts for the current 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 2 months after blastocyst freezing
Participants undergo in vitro maturation of immature oocytes using either Fertilo or MediCult IVM®, followed by fertilization, embryo growth to blastocyst stage, vitrification, and later embryo transfer for reproductive purposes.
Visits occur for oocyte retrieval, fertilization, embryo culture, and embryo transfer procedures
Duration - Up to greater than 24 weeks gestation
Participants are followed to monitor pregnancy outcomes including biochemical pregnancy, clinical pregnancy, and live birth.
Approximately 3 visits including follow-up at 10 to 14 days, 4 to 6 weeks, and after 24 weeks of gestation
Trial Site Locations
Total: 13 locations
1
Women's Specialty & Fertility Center
Clovis, California, United States, 93611
Actively Recruiting
2
HRC Fertility
Encino, California, United States, 91436
Actively Recruiting
3
Florida Fertility Institute
Clearwater, Florida, United States, 33759
Actively Recruiting
4
IVF Florida
Pembroke Pines, Florida, United States, 33026
Actively Recruiting
5
Shady Grove Fertility
Rockville, Maryland, United States, 20850
Actively Recruiting
6
Columbia University Fertility Center
New York, New York, United States, 10019
Actively Recruiting
7
Reach Fertility
Charlotte, North Carolina, United States, 28207
Actively Recruiting
8
Conceptions Fertility
Raleigh, North Carolina, United States, 27607
Actively Recruiting
9
Care Fertility
Bedford, Texas, United States, 76022
Actively Recruiting
10
Dallas Fort Worth Fertility Associates
Dallas, Texas, United States, 75231
Actively Recruiting
11
Aspire Fertility San Antonio
San Antonio, Texas, United States, 78528
Actively Recruiting
12
Shady Grove Houston
Webster, Texas, United States, 77598
Actively Recruiting
13
Utah Fertility Center
Pleasant Grove, Utah, United States, 84062
Actively Recruiting
Research Team
C
Clinical Trials
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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