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First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Primary Purpose

Primary Uterine Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Uterus transplantation
Sponsored by
Amro M. Hetta, M.Sc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Uterine Infertility focused on measuring uterus, transplantation, infertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Less than 45 years old
  • Good general health

Exclusion Criteria:

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

Sites / Locations

  • Mansoura Urology and Nephrology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Uterus Transplantation

Arm Description

Patients undergo transplantation of the uterus from a live donor

Outcomes

Primary Outcome Measures

Surviving transplants (8-12 months)
Follow up

Secondary Outcome Measures

Spontaneous menstruation commencement
Observation
Pregnancy rate
IVF treatment
Live birth rate
IVF treatment

Full Information

First Posted
September 13, 2017
Last Updated
March 29, 2021
Sponsor
Amro M. Hetta, M.Sc.
Collaborators
Al-Azhar University, Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03284073
Brief Title
First Clinical Live-Donor Uterus Transplantation Trial In Egypt
Official Title
First Clinical Live-Donor Uterus Transplantation Trial In Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amro M. Hetta, M.Sc.
Collaborators
Al-Azhar University, Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Uterine Infertility
Keywords
uterus, transplantation, infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Human uterus transplantation from a live donor
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uterus Transplantation
Arm Type
Experimental
Arm Description
Patients undergo transplantation of the uterus from a live donor
Intervention Type
Procedure
Intervention Name(s)
Uterus transplantation
Other Intervention Name(s)
UTx
Intervention Description
Transplantation of the uterus from a live donor and IVF treatment
Primary Outcome Measure Information:
Title
Surviving transplants (8-12 months)
Description
Follow up
Time Frame
Up to 3 years after transplantation
Secondary Outcome Measure Information:
Title
Spontaneous menstruation commencement
Description
Observation
Time Frame
Up to 3 months after transplantation
Title
Pregnancy rate
Description
IVF treatment
Time Frame
Up to 3 years after transplantation
Title
Live birth rate
Description
IVF treatment
Time Frame
Up to 4 years after transplantation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amro M. Hetta, M.Sc.
Phone
+201281283482
Email
doctor.hetta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amro M. Hetta, M.Sc.
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura Urology and Nephrology Center
City
Mansoura
State/Province
Al-Dakahliya
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Scientific publications and Prospective thesis of MD Degree
Citations:
PubMed Identifier
24582522
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
27868389
Citation
Molne J, Broecker V, Ekberg J, Nilsson O, Dahm-Kahler P, Brannstrom M. Monitoring of Human Uterus Transplantation With Cervical Biopsies: A Provisional Scoring System for Rejection. Am J Transplant. 2017 Jun;17(6):1628-1636. doi: 10.1111/ajt.14135. Epub 2017 Jan 3.
Results Reference
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PubMed Identifier
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Citation
Fageeh W, Raffa H, Jabbad H, Marzouki A. Transplantation of the human uterus. Int J Gynaecol Obstet. 2002 Mar;76(3):245-51. doi: 10.1016/s0020-7292(01)00597-5.
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Citation
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Results Reference
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PubMed Identifier
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Citation
Ghanem ME, El-Baghdadi LA, Badawy AM, Bakr MA, Sobhe MA, Ghoneim MA. Pregnancy outcome after renal allograft transplantation: 15 years experience. Eur J Obstet Gynecol Reprod Biol. 2005 Aug 1;121(2):178-81. doi: 10.1016/j.ejogrb.2004.11.035.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
Jarvholm S, Johannesson L, Clarke A, Brannstrom M. Uterus transplantation trial: Psychological evaluation of recipients and partners during the post-transplantation year. Fertil Steril. 2015 Oct;104(4):1010-1015. doi: 10.1016/j.fertnstert.2015.06.038. Epub 2015 Jul 28.
Results Reference
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PubMed Identifier
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Citation
Jarvholm S, Johannesson L, Brannstrom M. Psychological aspects in pre-transplantation assessments of patients prior to entering the first uterus transplantation trial. Acta Obstet Gynecol Scand. 2015 Oct;94(10):1035-8. doi: 10.1111/aogs.12696. Epub 2015 Jun 30.
Results Reference
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Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://clinicaltrials.gov
Available IPD/Information Identifier
NCT01844362

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First Clinical Live-Donor Uterus Transplantation Trial In Egypt

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