NCT05726305 Transplantation of Uterus for Uterine infertiLIty From Living Donor or Deceased Donor
| NCT ID | NCT05726305 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Uterine Factor Infertility |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-01-23 |
| Primary Completion | 2037-12 |
Trial Parameters
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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).
Eligibility Criteria
Inclusion Criteria for UT recipient: * 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. Inclusion Criteria for a deceased brain-dead uterus donor: * 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). Inclusion Criteria for a live uterus donor: * Patient belonging to the family of the recipient (mother, sister, aunt, mother-in-law...) or any person