Can a transplanted uterus make pregnancy possible for women born without one?

NCT ID NCT03307356

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether a uterus transplanted from a living or deceased donor can allow women with uterine factor infertility to carry a pregnancy and give birth. The study plans to enroll 10 women who will receive a transplant, undergo embryo transfer, and attempt delivery, followed by removal of the transplanted uterus. Researchers will also accept women interested in donating their uterus. The goal is to see if the transplanted uterus can function well enough to result in a live-born child.

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 living or deceased donor
What this could lead to
If successful, this could offer a path to biological motherhood for women with uterine factor infertility, who currently have limited options.
What could go wrong
This is a small, early-stage trial with only 10 participants. The transplant carries risks like rejection, infection, and complications from surgery or pregnancy, and 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

10 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Jul 2029

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

21 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.

Uterine Transplant Recipient Participant Inclusion Criteria: 1. XX-bearing individual diagnosed with Uterine Factor Infertility (UFI) a 2. Age 21-40 3. Lives in Philadelphia region for the duration of the trial 4. Received counseling regarding alternatives to uterine transplant such as adoption or surrogacy 5. Intact ovaries 6. Vaginal length \>6 cm (average vaginal length established with dilators) 7. Body mass index \<35 kg/m2 8. Fluent in the English Language 9. If cervix present/previously present, human papillomavirus (HPV)) negative or received vaccination for HPV 10. Willing to comply with screening, protocol and all required procedures 11. Has adequate social support 12. Has undergone controlled ovarian hyperstimulation, egg retrieval, in vitro fertilization, and embryo freezing and has frozen embryos of sufficient embryo quality/quantity (≥2 high quality blastocysts); (Required for Transplant Phase, not Screening or Evaluation Phases) Uterine Transplant Recipient Participant Exclusion Criteria: 1. Previous multiple major abdominal/pelvic surgery 2. Severe endometriosis 3. History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease 4. History of prior malignancy except for cervical cancer in stage 1a or 1b (must be in remission for 3 years) 5. History of significant psychiatric illness 6. Allergy, hypersensitivity, or intolerance of expected immunosuppressive agents (i.e. Thymoglobulin®, tacrolimus, etc.) 7. Allergy, hypersensitivity, or intolerance of heparin or aspirin 8. Presence of active documented systemic infection or recent systemic infection within the past 3 months 9. Seropositivity for HIV, HBV core antibody or antigen, HCV 10. Current smoker (smoking cessation must have occurred 3 months prior to enrollment) 11. Chemical and/or alcohol dependency or abuse 12. Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders) 13. Renal abnormalities, specifically single kidney or pelvic kidneys (imaging confirmation of 2 normal kidneys is required for MRKH subjects) 14. Contraindications to pregnancy 15. Unwilling to receive a transfusion of blood or blood products Living Donor Participant Inclusion Criteria: 1. Age 30-50 2. Has definitively completed childbearing 3. Live birth to miscarriage ratio ≥1 4. Body mass index \<35 kg/m2 5. Normal uterine anatomy 6. Normal pap test and Human papillomavirus (HPV) negative 7. Negative infection screen (HIV, HepB, HepC, Syphilis, gonorrhea, chlamydia) 8. Received counseling regarding alternatives to uterus donation such as adoption and gestational surrogacy 9. Fluent in the English Language 10. Willing to comply with screening, protocol and all required procedures 11. Has adequate social support 12. Compatible blood type with recipient 13. Negative flow cytometric crossmatch with recipient 14. Has current health insurance 15. Able to stay in the Philadelphia region for 3 weeks following uterus donation Living Donor Participant Exclusion Criteria: 1. Previous multiple major abdominal/pelvic surgery 2. Severe endometriosis 3. History of hypertension, diabetes mellitus, thrombophilia or other clotting or bleeding disorders, significant heart, liver, kidney or central nervous system disease 4. History or obvious evidence of previous multiple/significant uterine surgery. Defined as \>1 cesarean delivery and/or myomectomy 5. History of previous cervical surgery (cone biopsy or loop electrosurgical excision procedure) 6. Significant systemic disease (diabetes or systemic lupus erythematosus) 7. Previous obstetric problem including delivery \<34 weeks and abnormal placental location (i.e. placenta Previa/accreta/increta/percreta) 8. Pregnancy 9. Abnormal uterine cavity 10. Vascular calcification on imaging tests 11. History of significant psychiatric illness 12. Current smoker (smoking cessation must have occurred 3 months prior to enrollment) 13. Chemical and/or alcohol dependency or abuse 14. Psychosocial problems (including alcoholism, drug abuse, documented behavioral disorders) 15. Unwilling to receive a transfusion of blood or blood products 16. Evidence of coercion or exchange of money or goods for donating the organ Deceased Donor Inclusion Criteria: 1. Hemodynamically stable donor 2. Age between 18 to 50 years 3. Compatible blood type with recipient 4. Negative flow cytometric crossmatch with recipient 5. Live birth to miscarriage ratio ≥1 6. Normal gross uterine anatomy (as visually assessed by gynecologic surgeon at time of organ procurement) 7. Macroscopically normal cervix (polyp acceptable) 8. Negative infection screen (HIV, HepB, HepC, Syphilis) 9. Cytomegalovirus (CMV)- matched based on rapid donor screening. A CMV positive donor may be used in a CMV negative recipient. A CMV negative donor may be used in either a CMV positive or negative recipient. 10. Donates after brain death Deceased Donor Exclusion Criteria: 1. Current malignancy or history of malignancy active within the past 5 years (Except adequately treated localized basal or squamous cell carcinoma of skin without evidence of recurrence) 2. No history or obvious evidence of previous multiple/significant uterine surgery. Defined as \>1 cesarean delivery and/or myomectomy 3. No history or obvious evidence of previous cervical surgery (cone biopsy or loop electrosurgical excision procedure) 4. Significant systemic disease (i.e. diabetes, peripheral vascular or cardiovascular disease, autoimmune disease, renal or liver failure, etc.) 5. Previous obstetric problem including delivery \<34 weeks and abnormal placental location (i.e. placenta Previa/accreta/increta/percreta) 6. Pregnancy 7. BMI \>35 kg/m2 8. Donates after cardiac death (DCD)

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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

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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Other studies related to the condition(s) this trial covers.