Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)

Infertility of Uterine Origin Clinical Trial

Official title: Deceased Uterine Transplant in Absolute Uterine Infertility (AUIF)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Infertility
• Infertility of Uterine Origin
• Infertility, Female

• NCT number: NCT04026893
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Contact: Stefan G Tullius, MD
• Phone: 617-732-6866
• Email: stullius@bwh.harvard.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Completion date: October 1, 2025