What is Fertilo studying for in vitro maturation of oocytes?

Fertilo is being studied to see if it is better than the currently approved Medicult IVM system for helping eggs mature outside the body. The trial focuses on pregnancy outcomes in women undergoing IVF. It is sponsored by Gameto, Inc. to explore new options for infertility treatment.

Who may be eligible for this in vitro maturation of oocytes clinical trial?

Women aged 18 to 35 who are premenopausal and meet criteria for IVF may be eligible. Participants must have a BMI between 21 and 40 and no contraindications to certain medications. This trial is for females only. Please review eligibility criteria for more details.

Is there any cost to participate in this in vitro maturation of oocytes clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years - 35Years

FEMALE

Healthy Volunteers

ID06858111

Phase 3 Study Comparing Fertilo and Medicult IVM for Egg Maturation in Women Aged 18 to 35 Undergoing IVF

Led by Gameto, Inc. · Updated on 2026-06-04

500

Participants Needed

Research Sites

35 weeks

Total Duration

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

Age: 18Years - 35Years

FEMALE

Healthy Volunteers

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.

Research Team

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Phase 3 Study Comparing Fertilo and Medicult IVM for Egg Maturation in Women Aged 18 to 35 Undergoing IVF

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria