Womb transplant trial offers hope for women born without a uterus
NCT ID NCT02573415
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a uterus transplant from a deceased donor can help 10 women with uterine factor infertility (missing or damaged uterus) give birth. Participants first create embryos through IVF, then receive the transplant, and later attempt pregnancy. The main goal is to see how many successful live births occur, but recipients must take anti-rejection drugs long-term to keep the transplanted uterus.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2015
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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. Must meet criteria for uterine factor infertility 1. Prior hysterectomy 2. Congenital absence or malformation of the uterus preventing pregnancy c, Infertility due to uterine damage from prior injury or infection 2. Must be between the ages of 21-45 and the embryos must have been produced between the age of 21-39. (age at the time the embryos are produced, not current age) 3. Must be willing to undergo a psychiatric and social work pre-transplant evaluation 4. Must be willing to undergo general anesthesia, in vitro fertilization, major gynecologic surgery, pregnancy with potential high risk complications, cesarean delivery and eventual hysterectomy to remove the graft 5. Must be willing and able to receive potent immunosuppressive medications and must be able to follow standard infection prophylaxis protocols 6. Must be willing to receive standard vaccinations such as influenza, pneumococcus, human papillomavirus (HPV) and hepatitis B 7. Must be willing and able to sign informed consent and follow all outlined procedures and recommendations in the protocol Exclusion Criteria: 1. History of hypertension, diabetes, or significant heart, liver, kidney or central nervous system disease 2. Any medical diagnosis placing the subject at high risk of surgical complications based on the transplant team's review of medical history. 3. Current smoker (smoking cessation must have occurred 3 months prior to enrollment) 4. History of prior malignancy except for cervical cancer in stage 1a or 1b after 3 years. 5. Human immunodeficiency virus, mycobacteria, hepatitis B (Hepatitis risk is for those with hepatitis B (HB) surface and/or core antigen and/or hepatitis B virus (HBV) DNA positive. Thos that are HB core antibody positive are at minimal risk and everyone else is not at risk), or hepatitis C. 6. Presence of active documented systemic infection or recent systemic infection within the past three months 7. Chemical and/or alcohol dependency or abuse 8. Presence of low lying pelvic kidney(s). Pelvic and horse shoe kidneys are common in the Rokitansky syndrome, and occur with a frequency as high as 30-40%. These abnormalities are usually known to subjects as part of their Mullerian agenesis diagnosis. If the patient is unsure about the status of their kidneys, the performance of a renal ultrasound is considered standard of care. These patients need to be informed of any kidney abnormalities, as they are frequently associated with kidney stones or obstructive kidney disease. 9. BMI greater than 30 kg/m2
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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
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Cleveland Clinic
Cleveland, Ohio, 44195, United States