Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor

Not Applicable

Recruiting

• Conditions: Uterine Factor Infertility
• Interventions: Procedure: Deceased donor uterus transplantation; Procedure: Live donor uterus transplantation

• Registration Number: NCT05726305
• Lead Sponsor: Rennes University Hospital

Brief Summary

Patients with absolute Uterine Factor Infertility (AUFI) are infertile due to the absence of a uterus. The absence of a uterus can be either iatrogenic (hysterectomy for gynecological pathology such as cancer or for obstetric pathology such as postpartum hemorrhage with hysterectomy for hemostasis), or congenital with utero-vaginal agenesis including Mayer Rokitansky Küster Hauser syndrome (MRKH) is the most common syndrome of uterine agenesis.

Alongside the AUFI, there is Non-Absolute Uterine Factor Infertility (NAUFI) which corresponds to patients with a uterus in place but which is altered by different pathologies, most often acquired, making it unsuitable for embryonic implantation and preventing the patient to get pregnant.

Uterus Transplantation (UT) represents an interesting alternative to the treatment of AUFI and potentially NAUFI (in the event of a uterus present but unsuitable for implantation) to access parenthood, especially since it is the only proposal that allows the patient to be both the surrogate mother, the biological mother (in case of simple donation) and the legal mother.

Many animal experiments have been accelerated since the beginning of the 21st century demonstrating that uterus transplantation was technically feasible and that pregnancy was possible.

In humans, several teams have recently performed several uterus transplants and have shown that this procedure is possible whether the donor is alive or dead (state of brain death).

In France, two teams (Foch and Limoges) have developed a uterus transplantation program. One in the context of living donors and the other of a deceased donors.

At the University Hospital of Rennes, we want to offer a UT program allowing access to a living or deceased donor for women with AUFI (type 1 or 2 MRKH syndrome and hysterectomy).

Detailed Description

Methods: Sixteen UT will be performed in total in 2 parallel arms: 8 UT from a live donor and 8 UT from a deceased brain-dead donor. Patients who have no suitable live donor will be wait-listed for a deceased donor.

Phases of the UT procedure: selection, in vitro fertilization and cryopreservation of embryos, uterus retrieval from a live donor or from a deceased donor, orthotopic uterus transplantation , follow up period (12 months), embryo transfer, pregnancy, child birth via Cesarian section (2 children maximum), later graft hysterectomy.

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-13
• Study Start: 2024-01-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2037-12
• Study Completion: 2037-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deceased donor uterus transplantation	Deceased donor uterus transplantation	Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.
Live donor uterus transplantation	Live donor uterus transplantation	Transplantation of uterus from a living donor. Immunosuppression with tacrolimus.

Primary Outcome Measures

Name	Time	Method
Efficacy of uterus transplantation	6 months after uterus transplantation	Show a functional uterus validated by the onset of menstruation and maintenance of menstruation 6 months after the uterine transplant has been performed
Security of uterus transplantation	Throughout the UT program	The number of living children resulting from uterine transplantation relative to the number of recorded complications defined by grade 3 complications of Clavien Dindo (complications of uterine transplant surgery in the post-operative month) and non-reversible complications of immunosuppressants (such as sequelae hypertension, blood disease, etc.).

Trial Locations

Locations (1)

Vincent LAVOUE; 🇫🇷 Rennes, France