Actively Recruiting
Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
Led by Brigham and Women's Hospital · Updated on 2026-04-28
250
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the world, we will identify emotionally and socially stable females of reproductive age with intact ovaries who are unable to gestate a child due to congenital or acquired uterine factor infertility. After careful screening, participants will undergo egg harvest, in vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete the fertilization of at least six euploid embryos will be eligible to be placed on the waitlist for a deceased donor uterus transplant. After a successful transplant and a period of observation to ensure normal menstrual cycle and graft viability (anticipate six months), embryo implantation will be undertaken. Following an embryo transfer, gestation will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include the surgical implantation of a uterus utilizing techniques by teams that have applied this approach successfully, close post-transplant follow up including immunosuppression therapy tailored to established standards during pregnancy minimizing fetal risks, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed either during Cesarean or during an elective procedure. In addition, open ended interviews and surveys will be conducted to elicit ethical and psychosocial concerns arising from the experience of subjects and their families, health care providers, and the wider community. The investigator's intent is to monitor outcomes for transplant recipients as well as the live born infants for 30 days after removal of the transplanted uterus. It is estimated that the time from screening to a potential live birth will be a minimum of 22 months, but likely between 24 - 36 months depending on organ availability.
CONDITIONS
Official Title
Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of absolute uterine factor infertility confirmed by a Brigham and Women's Hospital gynecologist
- Ability to produce at least six euploid embryos for cryopreservation
- Body mass index (BMI) of 30 or less
- Glomerular filtration rate (GFR) of 60 or greater, including patients with a single kidney
- Panel reactive antibody (PRA) level of 20% or less
- Medically and psychologically stable as determined by transplant team including psychiatry, social work, and study doctors
- Proven ability to comply with follow-up visits and immunosuppression treatment
- Partner willing to undergo psychological evaluation and receive recommended immunizations
- Stable home environment to support raising a child
You will not qualify if you...
- Active smoking, alcohol use, or illicit drug use
- Inability to follow strict medication schedules and attend required follow-up after transplant
- Medical conditions increasing surgical or pregnancy risk or risk from anti-rejection medications as determined by specialists
- Active infections including HIV, Hepatitis B, or Hepatitis C
- Insufficient blood vessels to support the transplanted uterus
- History of extensive abdominal or pelvic surgery
- Presence of a pelvic kidney
- History of abnormal Pap smear
- HPV-related vulvar, vaginal, or cervical dysplasia
- Evidence of genital warts (condylomata)
- History of pelvic inflammatory disease (PID)
- Having one or more living biological children
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Stefan G Tullius, MD
CONTACT
S
Shannon Weiss
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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