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

NCT05726305 | Recruiting

• 1 other identifier: 35RC20_9902_TULIPE
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Uterine Factor Infertility

Outcome Measures

Primary Outcomes (2)

• Efficacy of 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

  6 months after uterus transplantation

• Security of uterus transplantation

  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.).

  Throughout the UT program

Study Arms (2)

Live donor uterus transplantation

EXPERIMENTAL

Transplantation of uterus from a living donor. Immunosuppression with tacrolimus.

Procedure: Live donor uterus transplantation

Deceased donor uterus transplantation

EXPERIMENTAL

Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.

Procedure: Deceased donor uterus transplantation

Interventions

Live donor uterus transplantation PROCEDURE

Transplantation of uterus from a living donor.

Live donor uterus transplantation

Deceased donor uterus transplantation PROCEDURE

Transplantation of uterus from a deceased brain-dead donor.

Deceased donor uterus transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 to 40 at the time of the UT;
• BMI (Body Mass Index) ≤ 30 kg/m²;
• With AUFI (type 1 or 2 MRKH syndrome and hysterectomy);
• Informed about the possibility of adoption;
• Compatibility with the donor (ABO group, Human Leukocyte Antigen (HLA) typing);
• Up-to-date vaccinations;
• Able to reach the transplant center in less than 11 hours (applicable only for the "deceased donor" arm);
• Having a parental project that is formulated by a heterosexual couple, by a couple of women or by a single woman;
• Vaginal cup of length greater than or equal to 7 cm.
• Any person who is brain dead and who has been duly diagnosed with the following criteria: Female gender;Age ≤ 42 years;Compatibility with the recipient (ABO group, HLA typing).
• Patient belonging to the family of the recipient (mother, sister, aunt, mother-in-law...) or any person who can prove a stable emotional relationship for more than 2 years with the recipient (paragraphs 1 and 2 of Article L.1231-1 of the Public Health Code);
• Age ≥ 37 years and ≤ 62 years ;
• BMI ≤ 30 kg/m²;
• Having completed all her parenthood plans and no longer having any plans of pregnancy;
• Having had at least one live-born child at term (i.e. after 37 weeks of of amenorrhea);

You may not qualify if:

• Patient with acquired uterine infertility and having had one or more children;
• Non-stable psychological state defined by a clinical psychologist after a qualitative interview;
• Severe co-morbidity;
• Association of severe abnormality with MRKH syndrome other than renal such as a cardiac malformation;
• A single pelvic kidney (urinary malformation that can be associated with MRKH syndrome);
• Pathogenic parental genetic anomaly which may lead to medical termination of pregnancy in the current state of knowledge;
• Diabetes (HbA1c \> 6%);
• Disorders of hemostasis: Prothrombin rate \<70%;
• Hemoglobin abnormality;
• Existence of hypertension;
• Vaginal reconstruction (neovagina) by digestive segment (colonic plastic surgery or other);
• History of major abdominal or pelvic surgery;
• Known thrombophilia (acquired or constitutional);
• HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HAV (Hepatitis A Virus), HTLV (Human T-Lymphotropic Virus) serology positive and presence of irreversible communicable infectious diseases;
• Positive vaginal hPV-HR (human Papilloma Virus High Risk) test;

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Vincent LAVOUE

Rennes, France

RECRUITING

Study Officials

• Vincent LAVOUE

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent LAVOUE

CONTACT

299265971; vincent.lavoue@chu-rennes.fr

Ludivine DION

CONTACT

ludivine.dion@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Living donor versus deceased donor

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 13, 2023
• Study Start: January 23, 2024
• Primary Completion (Estimated): December 1, 2037
• Study Completion (Estimated): December 1, 2037
• Last Updated: July 29, 2025

Record last verified: 2025-05

Locations

FR (1)