Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05726305

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

Led by Rennes University Hospital · Updated on 2025-07-29

16

Participants Needed

1

Research Sites

723 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 to 40 at the time of the uterus transplantation
  • Body Mass Index (BMI) of 30 kg/m² or less
  • Diagnosis of absolute uterine factor infertility (type 1 or 2 MRKH syndrome or hysterectomy)
  • Informed about the possibility of adoption
  • Compatibility with donor based on ABO blood group and HLA typing
  • Up-to-date vaccinations
  • Able to reach the transplant center within 11 hours (for deceased donor arm)
  • Having a parental plan as a heterosexual couple, female couple, or single woman
  • Vaginal length of 7 cm or greater
  • For deceased donor: female, age 42 or younger, compatible with recipient
  • For living donor: family member or person with stable emotional relationship over 2 years
  • Living donor age between 37 and 62 years
  • Living donor BMI 30 kg/m² or less
  • Living donor completed childbearing plans with at least one live-born child at term
  • Living donor has normal uterine imaging and satisfactory uterine vessels
Not Eligible

You will not qualify if you...

  • Recipient has acquired uterine infertility and has had children
  • Unstable psychological state as determined by clinical psychologist
  • Severe co-morbidities
  • Severe abnormalities associated with MRKH other than renal issues
  • Single pelvic kidney
  • Parental genetic anomalies that could lead to pregnancy termination
  • Diabetes with HbA1c over 6%
  • Blood clotting disorders with prothrombin rate below 70%
  • Hemoglobin abnormalities
  • Hypertension
  • Vaginal reconstruction using digestive segment
  • History of major abdominal or pelvic surgery
  • Known thrombophilia
  • Positive for HIV, Hepatitis B, C, A, HTLV, or irreversible infectious diseases
  • Positive high-risk HPV test
  • Signs of chronic kidney disease
  • Current or recent drug addiction or excessive alcohol use
  • Cancer history less than 10 years old or ongoing treatment (except certain skin lesions)
  • History of pelvic radiotherapy or vaginal brachytherapy
  • Known psychiatric disorders
  • Active tuberculosis
  • Contraindications to study treatments
  • Organ dysfunction incompatible with transplantation
  • Smoking history over 20 packs/year not quit for at least 2 years or current smoker
  • For deceased donors: circulatory arrest over 10 minutes, opposition to donation, uncontrolled hypertension, uterine absence or pathology, recent delivery or pregnancy, multiple caesarean sections, major surgery history, infections, risk of prion diseases, positive EBV if recipient negative, positive crossmatch or ABO incompatibility, drug addiction or excessive alcohol use, recent cancer, active tuberculosis, smoking history
  • For living donors: unstable psychological state, severe co-morbidities, diabetes with high HbA1c, clotting or hemoglobin disorders, hypertension treated with multiple drugs, recent delivery or pregnancy, cervical pathology, recurrent miscarriage syndrome, premature delivery history, pre-eclampsia, caesarean sections, major uterine or abdominal surgery, abnormal endometrial biopsy, thrombophilia, positive infectious disease tests, kidney disease, prion disease risk, drug addiction or excessive alcohol use, recent cancer, prior radiotherapy, psychiatric disorders, active tuberculosis, thromboembolic risk, vascular anomalies incompatible with transplantation, smoking history.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vincent LAVOUE

Rennes, France

Actively Recruiting

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Research Team

V

Vincent LAVOUE

CONTACT

L

Ludivine DION

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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