Uterine Transplant in Absolute Uterine Infertility (AUIF)
Key facts
- Who runs it
- Brigham and Women's Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2/3
- Started
- Sept 2026
- Expected to end
- Jun 2028
- Type of study
- Interventional
- Treatments tested
- Uterine Transplant
- Record updated
- 15 October 2026
- Why it stopped
- Attempts to renew our protocol have not been accepted. Also, composition of the team and institutional goals have changed.
Who can take part
- Age
- 18 years to 40 years
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 35 criteriaShow less
Who cannot take part
- Active smoking, alcohol use or use of illicit drugs
- Previous pregnancies were carried to term (no miscarriages)
- Active smoking, alcohol use or use of illicit drugs
- Internal scarring from extensive abdominal or pelvic surgery
- 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
- Psychiatric illness
- History of more than 1 Caesarean section
- History of abnormal PAP smear or genital warts
- 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
- Age over 40 up to age 60
- Inability to comply with required treatment (taking pills, having biopsies, frequent appointments )
- Has completed having a family
- Able to take a birth control pill containing estrogen
- Weight reasonable with BMI (Body Mass Index) of 30 or less
- Good social supports
- Cervical or endometrial polyps (growths) or tumors in the uterus muscle
- Evidence of coercion or exchange of money or goods for donating the organ
Other criteria
- 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
Where in United States
- Brigham and Women's HospitalBoston, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Women with AUFITreatment being tested
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.
Treatment: Uterine Transplant
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 15 October 2026