Womb transplants could let infertile women give birth

NCT ID NCT02656550

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ยท Last updated Jun 27, 2026

Summary

This study is testing whether a uterus transplant from a living or deceased donor can help women who were born without a uterus or had it removed to have a baby. Up to 38 women with working ovaries will receive a transplant and then try to get pregnant through IVF. The main goal is a successful live birth, but women will need to take anti-rejection drugs for life, so this is a disease-control approach, not a cure.

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

38 people

The number who actually took part.

Started

Nov 2015

Expected to finish

Nov 2026

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

20 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: 1. Women diagnosed with Absolute Uterine Infertility (AUI) and intact native ovaries. 2. Women of childbearing age 20-35. 3. Human papillomarvius negative or received vaccination for human papillomarvius virus (HPV). Subjects with a history of HPV in the past must show a negative history since and test negative at screening. 4. A subject who is negative for Gonorrhea, Chlamydia and Syphilis. 5. A subject with the history of Herpes (HSV-2) with no current symptoms. Subject may require preventative maintenance per study doctor discretion. 6. Subjects have received counseling regarding infertility alternatives to uterine transplant such as adoption or surrogate pregnancy. 7. Willing to undergo in-vitro fertilization and medically cleared for in-vitro fertilization. 8. Evaluated by a fertility specialist and determined to have good ovarian reproductive potential and ability to carry fetus to term. 9. Must have the ability to fund, either through third party coverage or through other their own personal financing, any expenses associated with assisted reproduction services provided to them. 10. Meets physiological recipient criteria Exclusion Criteria: 1. Subject with Diabetes Mellitus Type I and II by medical history or elevated hemoglobin A1c blood test. 2. Subject has known hypersensitivity to Tacrolimus, Thymoglobulin or CellCept. 3. Subject with existing hypertension, per investigator's discretion. 4. Subject who has a history of solid organ or bone marrow transplant. 5. Subject who has history of cancer in last five years. 6. Subject with a body mass index \>30. 7. Subject with an active infection. 8. Subject who is seropositive for HIV, HBV, HCV 9. Subject with technical obstacles as per anatomical malformations, which pose a high surgical risk in the judgment of the investigator. 10. Subject unwilling or unable to comply with study requirements. 11. Subject unable to undergo in-vitro fertilization or not cleared for transplant. 12. Subject who has smoked within the last 12 months. 13. Subject who has alcohol or drug abuse within 12 months of screening. 14. Subject with any pre-existing clinical or medical conditions that would pose the subject at an increased risk, as per the investigator's discretion.

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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.

Contacts and locations

Locations

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States