Deceased-donor uterine transplant for women with uterine-factor infertility

Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)

We will try a uterus transplant from a deceased donor to help women with uterine-factor infertility who can produce embryos and meet health and psychosocial requirements.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04026893 on ClinicalTrials.gov

What this trial studies

The program will identify reproductive-age women with absent or nonfunctional uteri but intact ovaries and good psychosocial support. Participants will undergo egg retrieval, IVF, and embryo cryopreservation, and those who produce at least six euploid embryos will be eligible for placement on a deceased-donor uterus waitlist. After transplant and an observation period (about six months) to confirm graft viability and normal menstrual function, embryo transfer will be attempted and pregnancies will be managed by high-risk obstetrics. Candidates will receive standard immunosuppression and close multidisciplinary follow-up throughout the process.

Who should consider this trial

Good fit: Women of reproductive age with absolute uterine factor infertility, intact ovaries able to produce at least six euploid embryos, BMI ≤ 30, GFR ≥ 60, PRA ≤ 20%, and stable psychosocial support who pass medical and psychiatric screening are ideal candidates.

Not a fit: Women who cannot produce enough euploid embryos, have active substance use, unstable psychiatric or social situations, medical contraindications to major surgery or immunosuppression, or inability to adhere to follow-up and medication schedules are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this approach could allow women without a functional uterus to carry pregnancies and deliver using their own eggs.

How similar studies have performed: Uterine transplantation has led to pregnancies and live births at other centers—mostly from living donors—with deceased-donor programs less common but reported.

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

Where this trial is running

Boston, Massachusetts

• Brigham & Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Stefan G Tullius, MD — Brigham and Women's Hospital
• Study coordinator: Stefan G Tullius, MD

Conditions: Infertility of Uterine Origin, AUFI