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 range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
. 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
. 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.