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RECRUITING

NCT02741102

PHASE2/PHASE3

Uterine Transplant in Absolute Uterine Infertility (AUIF)

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07

Completion Date

2028-01

Last Updated

2026-07-06

Healthy Volunteers

Conditions

Female Infertility

Interventions

PROCEDURE

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.

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States