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Initiation of a Deceased Donor Uterine Transplantation Program at the University of Nebraska Medical Center

NCT02409147 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-15

No results posted yet for this study

Summary

This study will explore the feasibility of initiating a uterine transplant program at UNMC. Using the procedural templates established by a successful Swedish team, the investigators 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 (UFI). Women will be 21 to 35 years of age upon entry into the protocol, with normal ovarian reserve and otherwise healthy for pregnancy. After careful screening, participants will undergo egg harvest, in-vitro fertilization, and embryo cryopreservation using standard methods. Women who successfully complete in vitro fertilization and cryopreservation of at least six embryos will be eligible to receive implantation of a deceased donor uterus. After a period of observation to ensure normal menstrual cycling and graft viability, embryo implantation will be undertaken. Gestations will be carefully monitored by our high-risk pregnancy specialists. Medical research interventions include uterine harvest from a deceased donor, surgical implantation of the organ utilizing standard transplant techniques, careful post-transplant follow-up including immune suppression therapy tailored to minimize fetal compromise, and careful management of pregnancy. After childbearing is complete (at most two gestations), the donor uterus will be removed. In addition, open-ended interviews and written 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 investigators intent is to monitor outcomes lifelong for transplant recipients and live-born infants.

Conditions

  • Uterus Transplant

Interventions

PROCEDURE

Uterine Transplant

Surgical implantation of a deceased donor uterus, induction therapy with thymoglobulin or basiliximab, maintenance immunosuppression with Prograf, Cellcept, and Prednisone. Anti-infective treatment with Bactrim and Valcyte and Nystatin. Anti-platelet therapy with aspirin. IVF per standard protocol. At time of birth: ceasarean section. Ultimately, transplant hysterectomy.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Alexander T Maskin, MD · UNMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-07-24
Completion
2018-07-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409147 on ClinicalTrials.gov