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First Clinical Live-Donor Uterus Transplantation Trial In Egypt

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ClinicalTrials.gov Identifier: NCT03284073
Recruitment Status : Not yet recruiting
First Posted : September 15, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborators:
Al-Azhar University
Mansoura Urology and Nephrology Center
Information provided by (Responsible Party):
Amro M. Hetta, M.Sc., Talkha Central Hospital

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
Primary Uterine Infertility Procedure: Uterus transplantation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Human uterus transplantation from a live donor
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First Clinical Live-Donor Uterus Transplantation Trial In Egypt
Estimated Study Start Date : October 31, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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 Name: UTx




Primary Outcome Measures :
  1. Surviving transplants (8-12 months) [ Time Frame: Up to 3 years after transplantation ]
    Follow up


Secondary Outcome Measures :
  1. Spontaneous menstruation commencement [ Time Frame: Up to 3 months after transplantation ]
    Observation

  2. Pregnancy rate [ Time Frame: Up to 3 years after transplantation ]
    IVF treatment

  3. Live birth rate [ Time Frame: Up to 4 years after transplantation ]
    IVF treatment



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Less than 45 years old
  • Good general health

Exclusion Criteria:

  • Older than 45 years old
  • Poor ovarian reserve
  • Systematic or psychiatric disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284073


Contacts
Contact: Amro M. Hetta, M.Sc. +201281283482 doctor.hetta@gmail.com

Locations
Egypt
Mansoura Urology and Nephrology Center
Mansoura, Al-Dakahliya, Egypt, 35511
Sponsors and Collaborators
Amro M. Hetta, M.Sc.
Al-Azhar University
Mansoura Urology and Nephrology Center
Investigators
Principal Investigator: Amro M. Hetta, M.Sc. Al-Azhar University

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: NCT01844362

Publications:

Responsible Party: Amro M. Hetta, M.Sc., Principal Investigator, Talkha Central Hospital
ClinicalTrials.gov Identifier: NCT03284073     History of Changes
Other Study ID Numbers: OG4
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Scientific publications and Prospective thesis of MD Degree

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., Talkha Central Hospital:
uterus
transplantation
infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female