Clinical Trial: Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Infertility

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Uterine Transplantation and Pregnancy Induction in Women Affected by Absolute Uterine Factor Infertility

Brief Summary: This study aims to investigate the treatment of absolute uterine infertility (AUI) due to congenital or surgical absence of a uterus or presence of a nonfunctioning uterus. The investigators will follow a model based on a Swedish study to enroll 10 women with functioning ovaries and successfully transplant the uterus from either a living or cadaveric donor, with the goal of live birth after transplantation.

Detailed Summary:

INTRODUCTION

Absolute Uterine Factor Infertility (AUI) is due to congenital or surgical absence of a uterus or presence of a nonfunctional uterus. Until 2014 the only option for women affected by Absolute Uterine Factor Infertility (AUI) was adoption or surrogate motherhood.

Primary Objective

  • Successful living or deceased donor uterine transplants resulting in live birth.
  • Pregnancy rate via in vitro fertilization.

BACKGROUND

In 1991 the National Transplantation Pregnancy Registry (NTPR) was established to study the outcomes of female transplant recipients. In 2010 the NTPR had collected data on 2000 pregnancy outcomes. The NTRP database includes data not just on the pregnancy but on follow-up of both parents and their offspring. The first reported case of pregnancy after transplant was reported in 1958.

In 2011 25,787 solid organ transplant recipients (kidney, liver, pancreas, small bowel, heart & lung) of which:

  • 9662 were women
  • 3505 were of childbearing age
  • 765 were less than 17 years old and could potentially become pregnant later in life.

One of the benefits of receiving a kidney, liver, pancreas, small bowel, heart or lung transplant is the underlying disease that caused the subject to have a transplant is gone, therefore fertility returns. Pregnancy after transplant is increasingly common. This has led to an accumulation of data and knowled
Sponsor: Baylor Research Institute

Current Primary Outcome: Number of successful live births after uterine transplant and IVF. [ Time Frame: 2 years after transplant ]

Full term birth by cesarean section.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Baylor Research Institute

Dates:
Date Received: January 12, 2016
Date Started: November 11, 2015
Date Completion: January 2026
Last Updated: March 10, 2017
Last Verified: March 2017