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FIRSTFertilo vs Medicult for In Vitro Maturation in Young Adults

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What is being tested

Fertilo

+ Medicult IVM

BiologicalDevice
Who is being recruted

Urogenital Diseases

+ Genital Diseases

+ Infertility

From 18 to 35 Years
See all eligibility criteria
How is the trial designed

Other Study

Phase 3
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorGameto, Inc.
Study ContactClinical Trials
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 17, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on evaluating a new way to assist with the process of in vitro maturation (IVM) of eggs, which is a step in fertility treatments. The trial involves women aged 18 to 35 and aims to determine if a new product called Fertilo is more effective and safer than the existing product, Medicult IVM, in maturing eggs in a laboratory setting. This research is important as it could improve the chances of pregnancy for individuals undergoing fertility treatments by enhancing the process of maturing eggs outside the body. Participants in this study will be divided into two groups. One group will have their eggs, specifically cumulus oocyte complexes (COCs), matured in the Fertilo solution for 30 hours, while the other group will use the Medicult IVM solution for the same duration. The study measures success by comparing the number of ongoing pregnancies at 12 weeks gestation between the two groups. This approach allows researchers to directly assess which method might lead to better pregnancy outcomes, providing valuable information for improving fertility treatment strategies.

Official TitlePhase III Randomized Control Trial to Investigate the Safety and Efficacy of Fertilo Versus Medicult In Vitro Maturation (IVM)
Principal SponsorGameto, Inc.
Study ContactClinical Trials
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 35 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesInfertility

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Immature cumulus-oocyte complexes (COCs) are oocytes surrounded by cumulus cells that have not yet matured. The COCs are cultured in Fertilo coculture condition then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose.

Group II

Active Comparator
Immature COCs are cultured in the standard IVM system MediCult IVM® then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Recruiting

HRC Fertility

Encino, United StatesOpen HRC Fertility in Google Maps
Recruiting

Florida Fertility Institute

Clearwater, United States
Recruiting

IVF Florida

Pembroke Pines, United States
Recruiting

Shady Grove Fertility

Rockville, United States
Recruiting
11 Study Centers
FIRST | Fertilo vs Medicult for In Vitro Maturation in Young Adults | PatLynk