Uterine Transplant in Absolute Uterine Infertility (AUIF)

StatusWithdrawn
PhasePhase 2/3
Started

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Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: Attempts to renew our protocol have not been accepted. Also, composition of the team and institutional goals have changed. Show 10 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Enrollment target: estimated 3 to confirmed 0
    • Start date: Jul 2026 to Sep 2026
    • Primary endpoints: details revised at 1 of 1 entry
    • Primary completion moved earlier from Dec 2027 to May 2027
    • Study completion pushed from Jan 2028 to Jun 2028
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised
    • Publications: details revised at 10 of 11 entries
  2. Enrollment reduced: 10 → 3 participants
    • Start date: May 2026 to Jul 2026
    v4
  3. Phase: Not applicable to Phase 2/3v3 Show 6 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Jun 2022 to Dec 2027
    • Start date: Jun 2016 to May 2026
    • Study sites: 0 to 1
    • Study completion date: Jan 2023 to Jan 2028
    • Secondary endpoints: details revised at 3 of 5 entries
  4. Secondary endpoints revised (5)v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will examine the feasibility of initiating a uterine transplant program for Absolute Uterine Factor Infertility (AUFI) at Brigham and Women's Hospital. The investigators plan to screen 30 patients with a goal of enrolling 10 patients. (5 donors and 5 recipients) After careful screening, appropriate candidates will undergo IVF, Uterine Transplantation, Embryo Transfer, Pregnancy and Delivery. Once the uterus is explanted, five years of follow-up is planned.
Trial Details
NCT Number NCT02741102
Lead Sponsor Brigham and Women's Hospital
Conditions
(from sponsor)		 Female Infertility
Related terms Infertility, Infertility, Female
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov