Fertilo In Vitro Research Study and Trial (NCT06858111) | Clinical Trial Compass
RecruitingPhase 3
Fertilo In Vitro Research Study and Trial
United States500 participantsStarted 2025-04-17
Plain-language 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.
Who can participate
Age range18 Years – 35 Years
SexFEMALE
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Inclusion criteria
✓. Written informed consent.
✓. Premenopausal, Age 18-35.
✓. Body mass index (BMI) 21-40.
✓. 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).
✓. No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
✓. Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
✓. Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit.
✓. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit.
Exclusion criteria
What they're measuring
1
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
. History of recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
✕. Baseline prolactin levels greater than 30 ng/ml
✕. Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
✕. Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
✕. Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
✕. 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.
✕. Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.