Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)

Mass General Brigham

Status

Not yet enrolling

Conditions

Infertility of Uterine Origin

Treatments

Procedure: Uterine Transplant from Deceased Donor

Study type

Interventional

Funder types

Other

Identifiers

NCT04026893

2018P001782/PHS

Details and patient eligibility

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.

Enrollment

250 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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