First Clinical Live-Donor Uterus Transplantation Trial In Egypt
NCT ID: NCT03284073
Last Updated: 2021-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
11 participants
INTERVENTIONAL
2021-09-01
2022-10-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Uterus Transplantation
Patients undergo transplantation of the uterus from a live donor
Uterus transplantation
Transplantation of the uterus from a live donor and IVF treatment
Interventions
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Uterus transplantation
Transplantation of the uterus from a live donor and IVF treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good general health
Exclusion Criteria
* Poor ovarian reserve
* Systematic or psychiatric disease
18 Years
45 Years
FEMALE
Yes
Sponsors
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Al-Azhar University
OTHER
Mansoura University
OTHER
Amro M. Hetta, M.Sc.
OTHER_GOV
Responsible Party
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Amro M. Hetta, M.Sc.
Principal Investigator
Principal Investigators
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Amro M. Hetta, M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Al-Azhar University
Locations
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Mansoura Urology and Nephrology Center
Al Mansurah, Al-Dakahliya, Egypt
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Study Documents
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Document Type: Study Protocol
View DocumentOther Identifiers
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OG4
Identifier Type: -
Identifier Source: org_study_id
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