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New Egg-Maturing solution could boost IVF success

NCT ID NCT06858111

Disease control Sponsor: Gameto, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times

Summary

This study tests whether Fertilo, a new solution for maturing eggs outside the body, works better than the current standard (MediCult IVM) for women aged 18-35 undergoing IVF. About 500 participants will have their eggs treated with either Fertilo or MediCult, and researchers will compare how many achieve an ongoing pregnancy at 12 weeks. The goal is to see if Fertilo leads to more successful pregnancies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

In vitro maturation of oocytes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aspire Fertility Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • Aspire Fertility Dallas

    RECRUITING

    Addison, Texas, 75001, United States

  • Aspire Fertility San Antonio

    RECRUITING

    San Antonio, Texas, 78528, United States

    Contact Email: •••••@•••••

  • Care Fertility

    RECRUITING

    Bedford, Texas, 76022, United States

  • Columbia University Fertility Center

    RECRUITING

    New York, New York, 10019, United States

  • Conceptions Fertility

    RECRUITING

    Raleigh, North Carolina, 27607, United States

    Contact Email: •••••@•••••

  • Dallas Fort Worth Fertility Associates

    RECRUITING

    Dallas, Texas, 75231, United States

  • Florida Fertility Institute

    RECRUITING

    Clearwater, Florida, 33759, United States

  • HRC Fertility

    RECRUITING

    Encino, California, 91436, United States

    Contact Email: •••••@•••••

  • IVF Florida

    RECRUITING

    Pembroke Pines, Florida, 33026, United States

  • Reach Fertility

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Shady Grove Fertility

    RECRUITING

    Rockville, Maryland, 20850, United States

    Contact Email: •••••@•••••

  • Shady Grove Houston

    RECRUITING

    Webster, Texas, 77598, United States

  • Utah Fertility Center

    RECRUITING

    Pleasant Grove, Utah, 84062, United States

  • Women's Specialty & Fertility Center

    RECRUITING

    Clovis, California, 93611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.