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A Hormone-Free IVF path? Lab-Matured eggs put to the test

NCT ID NCT07801105

Disease control Sponsor: Kevin Doody 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This pilot study tests whether eggs can be collected from small ovarian follicles without the usual hormone injections. Women aged 18 to 35 with infertility will undergo up to three unstimulated egg retrievals. The eggs are matured in the lab using a device called CAPA-IVM, then fertilized and grown into embryos. Researchers will check how many chromosomally normal embryos result, and may transfer one if available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAPA-IVM System (a laboratory device for maturing eggs) and serial unstimulated transvaginal oocyte retrieval (a procedure to collect eggs without hormone injections)
What this could lead to
If this works, it could offer a gentler IVF path with fewer hormone injections, while still producing healthy embryos for transfer.
What could go wrong
This is a small pilot study, so success is not guaranteed. The approach may yield fewer embryos than standard stimulation, and the lab maturation process might not work for everyone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Signed informed consent. * Female participant aged 18-35 years. * Diagnosis of infertility requiring IVF/ICSI, including unexplained infertility or mild male factor infertility. * BMI 18-30 kg/m². * AMH ≥2.5 ng/mL. * AFC ≥12. * Basal FSH \<8 IU/L. * Ovaries accessible for transvaginal retrieval. * Willing to undergo serial unstimulated TVORs with adaptive retrieval timing. * Willing to undergo CAPA-IVM, ICSI, blastocyst culture, PGT-A, embryo vitrification/accumulation, and single euploid embryo transfer. * Willing to undergo serial ultrasound and endocrine monitoring. * Willing and able to comply with study procedures and follow-up. Exclusion Criteria: * Prior ovarian surgery. * Ovarian endometrioma. * Inaccessible ovaries. * Significant uterine factor expected to compromise implantation, pregnancy, or live birth. * Significant medical comorbidity that would increase risk of TVOR, pregnancy, or study participation. * AMH \<2.5 ng/mL. * AFC \<12. * Basal FSH ≥8 IU/L. * BMI \<18 or \>30 kg/m². * Current smoking or nicotine use within 3 months of screening. * Active pelvic infection, untreated STI, or acute urinary tract infection. * Contraindication to transvaginal oocyte retrieval, anesthesia/sedation, pregnancy, or antibiotic prophylaxis. * Known chromosomal abnormality in the participant or sperm source that would confound study outcome assessment. * Severe male factor infertility requiring surgical sperm retrieval, unless specifically permitted by the final protocol. * Recent exposure to teratogenic radiation, drugs, or toxins. * Current participation in another interventional clinical trial that may confound outcomes. * Previous participation in the CARE study.

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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.

Infertility

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • CARE Fertility Texas

    RECRUITING

    Bedford, Texas, 76104, United States

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