Evaluating Fertilo for In Vitro Maturation of Oocytes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of Fertilo compared to Medicult IVM for the in vitro maturation of oocytes in women aged 18-35. Participants will be randomly assigned to receive either Fertilo or Medicult IVM, with the primary outcome being the number of ongoing pregnancies at 12 weeks gestation. The study will involve culturing cumulus oocyte complexes for 30 hours in each treatment arm. This phase 3 trial seeks to determine if Fertilo offers a superior option for patients undergoing in vitro fertilization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent.
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:

1. History of recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
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.

Where it's running

• Women's Specialty & Fertility Center
  Clovis, California, United States Recruiting
• HRC Fertility
  Encino, California, United States Recruiting
• Florida Fertility Institute
  Clearwater, Florida, United States Recruiting
• IVF Florida
  Pembroke Pines, Florida, United States Recruiting
• Shady Grove Fertility
  Rockville, Maryland, United States Recruiting
• Columbia University Fertility Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: clinicaltrials@gametogen.com
• Phone: 512-535-1164

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IVM fresh embryo transfer (Saigon protocol) versus IVF with frozen embryo transfer for women with PCOS

  This trial tests whether in vitro maturation with a fresh embryo transfer (the Saigon protocol) helps women with PCOS get pregnant as well as conventional IVF followed by a frozen embryo transfer.

  Recruiting Mỹ Đức Hospital · Ho Chi Minh City · NCT07171970

• In vitro maturation of human eggs for fertility treatment

  This study is testing a new way to help women with fertility issues by maturing their eggs in the lab with fewer hormones to see if it makes treatment easier and safer.

  Recruiting Colorado Center for Reproductive Medicine · Lone Tree, Colorado · NCT06633120

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.