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First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Sponsor
Amro M. Hetta, M.Sc. (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03284073
Collaborator
Al-Azhar University (Other), Mansoura University (Other)
11
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and functional)].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Uterus transplantation
 N/A

Detailed Description

More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was the treatment which had been developed for women suffering from absolute uterine factor infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and functional)].

In Egypt, People's religions, current ethical and legal backgrounds make the option of live-donor uterus transplantation appealing rather than alternative pathways to parenthood. Thus, its clinical application for the first time in Egypt should be initiated after an extensive review and analysis of literature for UTx technology development in the world, and for further possible contributions to future prospects by Egypt proposed UTx project team which will participate in our study.

The study protocol includes live-donor UTx (mother, relative, friend) into women with AUFI. The recipient will be treated by standard immunosuppression and transfer of embryos (acquired by IVF before surgery) will be attempted after 8-12 months have passed from transplantation. Two official approvals must be obtained before starting recruitment process; from both (Higher Committee of Human Organ Transplantation of Egyptian Ministry of Health and Population, and Al-Azhar University Council).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Human uterus transplantation from a live donorHuman uterus transplantation from a live donor
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
First Clinical Live-Donor Uterus Transplantation Trial In Egypt
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Uterus Transplantation

Patients undergo transplantation of the uterus from a live donor

Procedure: Uterus transplantation
Transplantation of the uterus from a live donor and IVF treatment
Other Names:
  • UTx

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Surviving transplants (8-12 months) [Up to 3 years after transplantation]

      Follow up

    Secondary Outcome Measures

    1. Spontaneous menstruation commencement [Up to 3 months after transplantation]

      Observation

    2. Pregnancy rate [Up to 3 years after transplantation]

      IVF treatment

    3. Live birth rate [Up to 4 years after transplantation]

      IVF treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Less than 45 years old

    • Good general health

    Exclusion Criteria:

    • Older than 45 years old

    • Poor ovarian reserve

    • Systematic or psychiatric disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mansoura Urology and Nephrology Center Mansoura Al-Dakahliya Egypt 35511

    Sponsors and Collaborators

    • Amro M. Hetta, M.Sc.
    • Al-Azhar University
    • Mansoura University

    Investigators

    • Principal Investigator: Amro M. Hetta, M.Sc., Al-Azhar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amro M. Hetta, M.Sc., Principal Investigator, Talkha Central Hospital
    ClinicalTrials.gov Identifier:
    NCT03284073
    Other Study ID Numbers:
    • OG4
    First Posted:
    Sep 15, 2017
    Last Update Posted:
    Mar 30, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amro M. Hetta, M.Sc., Principal Investigator, Talkha Central Hospital
    uterus
    transplantation
    infertility
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Mar 30, 2021