NCT04026893 Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)
| NCT ID | NCT04026893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Infertility of Uterine Origin |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2026-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2026-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Stefan G Tullius, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT04026893 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Infertility of Uterine Origin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04026893 currently recruiting?
Yes, NCT04026893 is actively recruiting participants. Contact the research team at stullius@bwh.harvard.edu for enrollment information.
Where is the NCT04026893 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04026893 clinical trial?
NCT04026893 is sponsored by Brigham and Women's Hospital. The principal investigator is Stefan G Tullius, MD at Brigham and Women's Hospital. The trial plans to enroll 250 participants.