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Womb transplant trial offers hope for women with uterine infertility

NCT ID NCT04026893

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 07, 2026 · Updated 3 times

Summary

This study tests whether a uterus from a deceased donor can be transplanted into women who cannot get pregnant due to a missing or non-working uterus. Participants must first create and freeze at least six embryos through IVF. After transplant and recovery, embryos are implanted. The goal is to help these women carry and deliver a baby. Anti-rejection drugs are required throughout pregnancy, and the transplanted uterus is removed after one or two births.

What this could mean

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

Active substance
Uterine transplant from a deceased donor, plus anti-rejection medications
What this could lead to
If successful, this could offer women born without a uterus or who lost it a way to carry and give birth to their own child.
What could go wrong
This is an early feasibility study with many steps—egg retrieval, transplant, pregnancy—each with risks. Anti-rejection drugs are needed long-term and may affect mother and baby. Success is not guaranteed.

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 250 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 40 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: * Evidence of AUFI diagnosed by BWH gynecologist * Ability to produce at least 6 euploid embryos for cryopreservation * BMI ≤ 30 * GFR 60 or greater in any patient including those with a single kidney * PRA 20% or less * Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment * Evidence to be compliant with follow-up and immunosuppression * Partner willing to undergo psychological evaluation and receive immunizations as recommended * Stable home environment to support a child Exclusion Criteria: * Active smoking, alcohol use or use of illicit drugs * Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments. * Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon. * Active infection: HIV, Hepatitis B, Hepatitis C * Inadequate blood vessels to support the transplanted uterus. * Prior extensive abdominal or pelvic surgery * Presence of pelvic kidney * History of abnormal PAP * HPV related vulvar, vaginal or cervical dysplasia * Evidence of genital condylomata * History of PID * One or more living biological children

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Brigham & Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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