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

Study acronym: TULIPE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 29 wordsv9
  2. Minor Eligibility criteria revisedv8
  3. Minor Eligibility criteria revisedv7
  4. Minor Eligibility criteria expanded, about 9 wordsv6
  5. Minor Start date changed from estimate of Jan 2024 to Jan 23, 2024v5
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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
  2. Notable Start date: Sep 2023 to Jan 2024v3
  3. Notable Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 259 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05726305
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)
Uterine Factor Infertility
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov