Recruiting
Phase 2
Phase 3

Uterine Transplant

Sponsor:

Brigham and Women's Hospital

Code:

NCT02741102

Conditions

Female Infertility

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Uterine Transplant

Study Details

Brief summary:

This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.

Conditions

Female Infertility

Study ID

NCT02741102

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Women with AUFI

Women with AUFI must meet criteria for uterine transplant. In vitro fertilization to obtain 6 (screened) healthy embryos for cryo-preservation precedes uterine transplant from an appropriate donor The recipient will be required to take potent anti rejection medications including Thymoglobulin, Prednisone, Tacrolimus, Mycophenolate Mofetil (MMF) , later substituted with Azathioprine to avoid birth defects. One year later, up to 6 attempts using 1 screened embryo at a time will be tried to achieve pregnancy. During pregnancy, the high risk pregnancy and transplant teams will follow the recipient. The goal is a full term baby and delivery will be by Caesarian section. A second pregnancy may be attempted. Afterward, the uterus will be explanted.

Interventions

Uterine Transplant

Treating Absolute Uterine Factor Infertility by Uterus Transplant. Potential recipients undergo IVF to obtain 6 embryos for cryopreservation followed by live donor uterine transplant. After 1 year, embryo transfer is done to achieve pregnancy. Delivery is by Caesarian section. The recipient may have up to 2 children by these methods and then the uterus is removed so that immunosuppression can be stopped.

Primary outcome measure

  • Number of successful live births following uterus transplant/embryo transfer [ Time Frame: 2 years after uterine transplant ]

Central Contacts and Locations

Central contacts

Stefan G Tullius, M.D.

617-732-6866stullius@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Infertility
  • AUFI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-06.