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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Collaborators: Sahlgrenska University Hospital, Sweden; University Hospital, Motol
• Treatments: Tacrolimus

Criteria

Inclusion Criteria for UTx recipient:

• 18 - 40 years of age

• good general health

• congenital or acquired uterus absence

• desire for a child

Exclusion Criteria for UTx recipient:

• age over 40

• serious comorbidity

Inclusion Criteria for a live uterus donor:

• female

• 18 - 60 years of age

• maximum 4 child births

• maximum 1 Cesarian section

• good general health

Exclusion Criteria for a live uterus donor:

• age over 60

• hypertension with organ damage

• diabetes mellitus

• other serious comorbidity

Inclusion Criteria for a deceased brain-dead uterus donor:

• female

• age under 60

• no previous hysterectomy

• no previous uterus malignancy