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Uterine Transplant in Absolute Uterine Infertility (AUIF)

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Interventional

Study Phase: Phase 2/Phase 3

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

Participation Requirements

Sex: Female

Minimum Age: 18

Maximum Age: 40

Healthy Volunteers: f

View:

• 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

Locations

United States

Massachusetts

Brigham and Women's Hospital

RECRUITING

Boston

Contact Information

Primary

Stefan G Tullius, M.D.

stullius@partners.org

617-732-6866

Time Frame

Start Date: 2026-05

Estimated Completion Date: 2028-01

Participants

Target number of participants: 10

Treatments

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.

Related Therapeutic Areas

Infertility

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