Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study

Summary

Uterus transplantation (UTx) is the only causative treatment for congenital or acquired uterus absence. Individual cases of UTx from a live donor (LD UTx) with healthy child birth performed so far showed favourable outcomes. The present study will include both LD UTx and UTx from deceased donors after brain death (DBD UTx). The aim is treatment of uterine infertility by UTx. It is is an ethically justifiable life-promoting transplantation. Twenty UTx will be performed in 2 parallel arms: 10 LD UTx and 10 DBD UTx. Immunosuppression will be administered. Phases of the UTx procedure are: in vitro fertilization - cryopreservation of embryos - uterus retrieval - UTx - follow up - embryo transfer - pregnancy - child birth - later graft hysterectomy - life long follow up. Introduction of UTx into clinical practice may enable women with uterine infertility to have their own children.

Conditions

• Mayer Rokitansky Kuster Hauser Syndrome
• Mullerian Aplasia
• Uterus; Absence, Congenital
• Infertility, Female
• Uterus Absence, Acquired
• Absolute Uterine Factor Infertility

Interventions

PROCEDURE

Live donor uterus transplantation

Transplantation of uterus from a living donor.

PROCEDURE

Deceased donor uterus transplantation

Transplantation of uterus from a deceased brain-dead donor.

DRUG

Tacrolimus

Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.

Sponsors & Collaborators

• University Hospital, Motol

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Institute for Clinical and Experimental Medicine

  lead OTHER_GOV

Principal Investigators

• Jiri Fronek, Assoc Prof · Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-09

Primary Completion

2020-12-31

Completion

2025-12-31

Countries

• Czechia

Study Locations