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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Sep 2021

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

September 13, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed

4 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed

Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

September 13, 2017

Last Update Submit

March 29, 2021

Conditions

Primary Uterine Infertility

Keywords

uterustransplantationinfertility

Outcome Measures

Primary Outcomes (1)

Surviving transplants (8-12 months)
Follow up
Up to 3 years after transplantation

Secondary Outcomes (3)

Spontaneous menstruation commencement
Up to 3 months after transplantation
Pregnancy rate
Up to 3 years after transplantation
Live birth rate
Up to 4 years after transplantation

Study Arms (1)

Uterus Transplantation

EXPERIMENTAL

Patients undergo transplantation of the uterus from a live donor

Procedure: Uterus transplantation

Interventions

Uterus transplantationPROCEDURE

Transplantation of the uterus from a live donor and IVF treatment

Also known as: UTx

Uterus Transplantation

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsFemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Less than 45 years old
Good general health

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, Al-Dakahliya, 35511, Egypt

Location

Related Publications (12)

Brannstrom M, Johannesson L, Dahm-Kahler P, Enskog A, Molne J, Kvarnstrom N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gabel M, Groth K, Akouri R, Eklind S, Holgersson J, Tzakis A, Olausson M. First clinical uterus transplantation trial: a six-month report. Fertil Steril. 2014 May;101(5):1228-36. doi: 10.1016/j.fertnstert.2014.02.024. Epub 2014 Feb 27.
PMID: 24582522BACKGROUND
Wei L, Xue T, Tao KS, Zhang G, Zhao GY, Yu SQ, Cheng L, Yang ZX, Zheng MJ, Li F, Wang Q, Han Y, Shi YQ, Dong HL, Lu ZH, Wang Y, Yang H, Ma XD, Liu SJ, Liu HX, Xiong LZ, Chen BL. Modified human uterus transplantation using ovarian veins for venous drainage: the first report of surgically successful robotic-assisted uterus procurement and follow-up for 12 months. Fertil Steril. 2017 Aug;108(2):346-356.e1. doi: 10.1016/j.fertnstert.2017.05.039.
PMID: 28778283BACKGROUND
Brannstrom M, Johannesson L, Bokstrom H, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gabel M, Hanafy A, Hagberg H, Olausson M, Nilsson L. Livebirth after uterus transplantation. Lancet. 2015 Feb 14;385(9968):607-616. doi: 10.1016/S0140-6736(14)61728-1. Epub 2014 Oct 6.
PMID: 25301505BACKGROUND
Arnolds K, Gomez N, Berry A, Stadtlander K, Watson M, Tzakis A, Falcone T, Zimberg S. Assessment of an Alternative to the Uterine Vein for Venous Drainage in Human Uterine Transplantation: A Case Series Following Laparoscopic Hysterectomy. Gynecol Obstet Invest. 2016;81(5):436-41. doi: 10.1159/000442466. Epub 2016 Jan 22.
PMID: 26796796BACKGROUND
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.
PMID: 27868389BACKGROUND
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.
PMID: 11880127BACKGROUND
Johannesson L, Kvarnstrom N, Molne J, Dahm-Kahler P, Enskog A, Diaz-Garcia C, Olausson M, Brannstrom M. Uterus transplantation trial: 1-year outcome. Fertil Steril. 2015 Jan;103(1):199-204. doi: 10.1016/j.fertnstert.2014.09.024. Epub 2014 Oct 22.
PMID: 25439846BACKGROUND
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.
PMID: 16009483BACKGROUND
Jones BP, Saso S, Yazbek J, Smith JR. Uterine transplantation: past, present and future. BJOG. 2016 Aug;123(9):1434-8. doi: 10.1111/1471-0528.13963. Epub 2016 Mar 2. No abstract available.
PMID: 26931179BACKGROUND
Brannstrom M, Bokstrom H, Dahm-Kahler P, Diaz-Garcia C, Ekberg J, Enskog A, Hagberg H, Johannesson L, Kvarnstrom N, Molne J, Olausson M, Olofsson JI, Rodriguez-Wallberg K. One uterus bridging three generations: first live birth after mother-to-daughter uterus transplantation. Fertil Steril. 2016 Aug;106(2):261-6. doi: 10.1016/j.fertnstert.2016.04.001. Epub 2016 Apr 25.
PMID: 27125227BACKGROUND
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.
PMID: 26231464BACKGROUND
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.
PMID: 26073658BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

Amro M. Hetta, M.Sc.
Al-Azhar University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Amro M. Hetta, M.Sc.

CONTACT

+201281283482 doctor.hetta@gmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER GOV
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

September 1, 2021

Primary Completion

September 30, 2022

Study Completion

October 31, 2022

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG(1)

First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Uterus Transplantation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (12)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

Uterus Transplantation

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (12)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Available IPD Datasets

Locations