First Clinical Live-Donor Uterus Transplantation Trial In Egypt

March 29, 2021 updated by: Amro M. Hetta, M.Sc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Al-Dakahliya
      • Mansoura, Al-Dakahliya, Egypt, 35511
        • Mansoura Urology and Nephrology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Less than 45 years old
  • Good general health

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surviving transplants (8-12 months)
Time Frame: Up to 3 years after transplantation
Follow up
Up to 3 years after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spontaneous menstruation commencement
Time Frame: Up to 3 months after transplantation
Observation
Up to 3 months after transplantation
Pregnancy rate
Time Frame: Up to 3 years after transplantation
IVF treatment
Up to 3 years after transplantation
Live birth rate
Time Frame: Up to 4 years after transplantation
IVF treatment
Up to 4 years after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amro M. Hetta, M.Sc.

Collaborators

Mansoura University
Al-Azhar University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

October 31, 2022

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (ACTUAL)

September 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OG4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Scientific publications and Prospective thesis of MD Degree

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Study Protocol
    Information identifier: NCT01844362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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