Womb transplant trial offers hope for women born without a uterus

NCT ID NCT02741102

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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 Results may not be published yet.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

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Status unknown
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First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study aims to help 10 women with absolute uterine infertility (no uterus or one that doesn't work) have a baby through a uterus transplant from a donor. Participants will first undergo IVF to create embryos, then receive the transplant, followed by embryo transfer and pregnancy. After delivery, the uterus is removed, and women are followed for five years. The main goal is to see if a live birth is possible, while closely monitoring for complications like rejection or pregnancy issues.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 3 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

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.

Uterine Transplant Inclusion/Exclusion Criteria RECIPIENT:Inclusion Criteria * Age 18-40 * Clinical evidence of AUFI (Absolute Uterine Factor Infertility) * Able to produce at least 6 normal embryos by IVF for future use * Reasonable weight with BMI (Body Mass Index) less than 30. * Normal kidney function * Able to undergo transplant and be compliant with treatment * Has stable partner and social supports * 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 comply with required treatment (taking pills, having biopsies, frequent appointments ) * Having a condition that would make pregnancy or taking anti rejection medicines too risky. * Active infection: Human Immunodeficiency Virus (HIV) , Tuberculosis, Hepatitis B, Hepatitis C * History of extensive abdominal or pelvic surgery * History of abnormal Papanicolaou test (PAP smear) or genital warts * History of pelvic inflammatory disease DONOR:Inclusion criteria * Age over 40 up to age 60 * Has completed having a family * Previous pregnancies were carried to term (no miscarriages) * Able to take a birth control pill containing estrogen * Weight reasonable with BMI (Body Mass Index) of 30 or less * Good social supports Exclusion Criteria: * Active smoking, alcohol use or use of illicit drugs * Psychiatric illness * Cervical or endometrial polyps (growths) or tumors in the uterus muscle * History of more than 1 Caesarean section * History of abnormal PAP smear or genital warts * Internal scarring from extensive abdominal or pelvic surgery * Hypertension, Coronary artery disease, Chronic Obstructive Lung disease (emphysema) and Diabetes * Active cancer or incompletely treated cancer * Active infection including Human Immunodeficiency Disease (HIV) , Tuberculosis, Hepatitis B or Hepatitis C * Significant history of either blood clots or bleeding tendencies * Evidence of coercion or exchange of money or goods for donating the organ

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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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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