Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04026893

Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Infertility of Uterine Origin

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Stefan Tullius, MD

CONTACT

[email protected]

617-697-9294

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Uterine Transplant from Deceased Donor

Procedure

The recipient will be started on anti-rejection medications (as is routine for transplant recipients) prior to the OR. Standard of care anesthesia and line placement will take place. The recipient will be appropriately identified as an organ recipient and the donor organ identified per required transplant protocols already in place. The recipient team will then connect the vasculature and appropriate supporting structures for the uterus transplant. Once the organ has been re-perfused, the remainder of the operation will take place and the patient will be moved to the Intensive Care Unit and later to the transplant patient floor for standard monitoring.

Primary outcomes

  1. Number of Live Births Following Uterus Transplant

    Time frame: Within 5 years of transplant

    To provide motherhood options for women with AUIF as an alternative to surrogacy or adoption, via gestating and giving birth via Cesarean section to a live infant.

  2. Number of Surgically Successful Uterus Transplants

    Time frame: Within 3 months of transplant

    To achieve surgically successful uterus transplants.

Secondary outcomes

  1. Financial impact of deceased donor uterus transplantation

    Time frame: Through Study completion, up to 5 years post transplant

    To analyze the overall impact of deceased donor uterus transplantation costs relative to established alternative procedures such as adoption and surrogacy.

  2. Quality of life impact of deceased donor uterus transplantation

    Time frame: Through study completion, up to 5 years post transplant

    To analyze the overall impact of deceased donor uterus transplantation including changes in quality of life, relative to other established alternative procedures such as adoption and surrogacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon Weiss

CONTACT

[email protected]

617-525-9763

Stefan G Tullius, MD

CONTACT

[email protected]

617-732-6866

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 19, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.