Status:
UNKNOWN
Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Infertility of Uterine Origin
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Our study will explore the feasibility of initiating a deceased donor uterine transplant program in addition to the existing living donor IRB at BWH. Using the template established by teams around th...
Eligibility Criteria
Inclusion
- Evidence of AUFI diagnosed by BWH gynecologist
- Ability to produce at least 6 euploid embryos for cryopreservation
- BMI ≤ 30
- GFR 60 or greater in any patient including those with a single kidney
- PRA 20% or less
- Deemed stable and capable of undergoing transplant by the transplant team to include psychiatry, social work, and transplant coordinator and study doctors to assure compliance with treatment
- Evidence to be compliant with follow-up and immunosuppression
- Partner willing to undergo psychological evaluation and receive immunizations as recommended
- Stable home environment to support a child
Exclusion
- Active smoking, alcohol use or use of illicit drugs
- Inability to follow a strict medication dosing schedule post-transplant and adhere to required follow-up appointments.
- Any co-morbidities which would increase surgical risk, risk of pregnancy or the risk of taking anti-rejection medications as determined by the Maternal Fetal Specialist and Transplant Surgeon.
- Active infection: HIV, Hepatitis B, Hepatitis C
- Inadequate blood vessels to support the transplanted uterus.
- Prior extensive abdominal or pelvic surgery
- Presence of pelvic kidney
- History of abnormal PAP
- HPV related vulvar, vaginal or cervical dysplasia
- Evidence of genital condylomata
- History of PID
- One or more living biological children
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04026893
Start Date
September 1 2020
End Date
October 1 2025
Last Update
July 19 2019
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