First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Primary Uterine Infertility Clinical Trial

Official title:

First Clinical Live-Donor Uterus Transplantation Trial In Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03284073
• Other study ID #: OG4
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2021
• Source: Talkha Central Hospital
• Contact: Amro M. Hetta, M.Sc.
• Phone: +201281283482
• Email: doctor.hetta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 11
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Less than 45 years old
• Good general health

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infertility
• Primary Uterine Infertility

Intervention

Procedure:
• Uterus transplantation
Transplantation of the uterus from a live donor and IVF treatment

Locations

Country	Name	City	State
Egypt	Mansoura Urology and Nephrology Center	Mansoura	Al-Dakahliya

Sponsors (3)

Lead Sponsor	Collaborator
Amro M. Hetta, M.Sc.	Al-Azhar University, Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (12)

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. — View Citation

Brännström M, Bokström H, Dahm-Kähler P, Diaz-Garcia C, Ekberg J, Enskog A, Hagberg H, Johannesson L, Kvarnström N, Mölne 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. — View Citation

Brännström M, Johannesson L, Bokström H, Kvarnström N, Mölne J, Dahm-Kähler P, Enskog A, Milenkovic M, Ekberg J, Diaz-Garcia C, Gäbel 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. — View Citation

Brännström M, Johannesson L, Dahm-Kähler P, Enskog A, Mölne J, Kvarnström N, Diaz-Garcia C, Hanafy A, Lundmark C, Marcickiewicz J, Gäbel 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. — View Citation

Fageeh W, Raffa H, Jabbad H, Marzouki A. Transplantation of the human uterus. Int J Gynaecol Obstet. 2002 Mar;76(3):245-51. — View 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. — View Citation

Järvholm S, Johannesson L, Brännström 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. — View Citation

Järvholm S, Johannesson L, Clarke A, Brännström 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. — View Citation

Johannesson L, Kvarnström N, Mölne J, Dahm-Kähler P, Enskog A, Diaz-Garcia C, Olausson M, Brännström 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. — View Citation

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. — View Citation

Mölne J, Broecker V, Ekberg J, Nilsson O, Dahm-Kähler P, Brännström 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surviving transplants (8-12 months)	Follow up	Up to 3 years after transplantation
Secondary	Spontaneous menstruation commencement	Observation	Up to 3 months after transplantation
Secondary	Pregnancy rate	IVF treatment	Up to 3 years after transplantation
Secondary	Live birth rate	IVF treatment	Up to 4 years after transplantation