Uterine Transplant in Absolute Uterine Infertility (AUIF)
Brigham and Women's Hospital
10 participants
May 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria15
- 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
- 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 Criteria18
- 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
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02741102