<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03284073</url>
  </required_header>
  <id_info>
    <org_study_id>OG4</org_study_id>
    <nct_id>NCT03284073</nct_id>
  </id_info>
  <brief_title>First Clinical Live-Donor Uterus Transplantation Trial In Egypt</brief_title>
  <official_title>First Clinical Live-Donor Uterus Transplantation Trial In Egypt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amro M. Hetta, M.Sc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Al-Azhar University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Talkha Central Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was&#xD;
      the treatment which had been developed for women suffering from absolute uterine factor&#xD;
      infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and&#xD;
      functional)].&#xD;
&#xD;
      In Egypt, People's religions, current ethical and legal backgrounds make the option of&#xD;
      live-donor uterus transplantation appealing rather than alternative pathways to parenthood.&#xD;
      Thus, its clinical application for the first time in Egypt should be initiated after an&#xD;
      extensive review and analysis of literature for UTx technology development in the world, and&#xD;
      for further possible contributions to future prospects by Egypt proposed UTx project team&#xD;
      which will participate in our study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      More than a decade ago, uterus transplantation (UTx) as a highly experimental procedure was&#xD;
      the treatment which had been developed for women suffering from absolute uterine factor&#xD;
      infertility (AUFI) [uterus absence (congenital and surgical), or an abnormality (anatomic and&#xD;
      functional)].&#xD;
&#xD;
      In Egypt, People's religions, current ethical and legal backgrounds make the option of&#xD;
      live-donor uterus transplantation appealing rather than alternative pathways to parenthood.&#xD;
      Thus, its clinical application for the first time in Egypt should be initiated after an&#xD;
      extensive review and analysis of literature for UTx technology development in the world, and&#xD;
      for further possible contributions to future prospects by Egypt proposed UTx project team&#xD;
      which will participate in our study.&#xD;
&#xD;
      The study protocol includes live-donor UTx (mother, relative, friend) into women with AUFI.&#xD;
      The recipient will be treated by standard immunosuppression and transfer of embryos (acquired&#xD;
      by IVF before surgery) will be attempted after 8-12 months have passed from transplantation.&#xD;
      Two official approvals must be obtained before starting recruitment process; from both&#xD;
      (Higher Committee of Human Organ Transplantation of Egyptian Ministry of Health and&#xD;
      Population, and Al-Azhar University Council).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">October 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Human uterus transplantation from a live donor</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surviving transplants (8-12 months)</measure>
    <time_frame>Up to 3 years after transplantation</time_frame>
    <description>Follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spontaneous menstruation commencement</measure>
    <time_frame>Up to 3 months after transplantation</time_frame>
    <description>Observation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>Up to 3 years after transplantation</time_frame>
    <description>IVF treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>Up to 4 years after transplantation</time_frame>
    <description>IVF treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">11</enrollment>
  <condition>Primary Uterine Infertility</condition>
  <arm_group>
    <arm_group_label>Uterus Transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo transplantation of the uterus from a live donor</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Uterus transplantation</intervention_name>
    <description>Transplantation of the uterus from a live donor and IVF treatment</description>
    <arm_group_label>Uterus Transplantation</arm_group_label>
    <other_name>UTx</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than 45 years old&#xD;
&#xD;
          -  Good general health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Older than 45 years old&#xD;
&#xD;
          -  Poor ovarian reserve&#xD;
&#xD;
          -  Systematic or psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amro M. Hetta, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amro M. Hetta, M.Sc.</last_name>
    <phone>+201281283482</phone>
    <email>doctor.hetta@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura Urology and Nephrology Center</name>
      <address>
        <city>Mansoura</city>
        <state>Al-Dakahliya</state>
        <zip>35511</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24582522</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28778283</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25301505</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26796796</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27868389</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11880127</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25439846</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16009483</PMID>
  </reference>
  <reference>
    <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. No abstract available.</citation>
    <PMID>26931179</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27125227</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26231464</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26073658</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Talkha Central Hospital</investigator_affiliation>
    <investigator_full_name>Amro M. Hetta, M.Sc.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>uterus</keyword>
  <keyword>transplantation</keyword>
  <keyword>infertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Scientific publications and Prospective thesis of MD Degree</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>NCT01844362</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://clinicaltrials.gov</doc_url>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03284073
org study id: OG4
nct id: NCT03284073
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Human uterus transplantation from a live donor
primary purpose: Treatment
masking: None (Open Label)
measure: Surviving transplants (8-12 months)
time frame: Up to 3 years after transplantation
description: Follow up
measure: Spontaneous menstruation commencement
time frame: Up to 3 months after transplantation
description: Observation
measure: Pregnancy rate
time frame: Up to 3 years after transplantation
description: IVF treatment
measure: Live birth rate
time frame: Up to 4 years after transplantation
description: IVF treatment
arm group label: Uterus Transplantation
arm group type: Experimental
description: Patients undergo transplantation of the uterus from a live donor
intervention type: Procedure
intervention name: Uterus transplantation
description: Transplantation of the uterus from a live donor and IVF treatment
arm group label: Uterus Transplantation
other name: UTx
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amro M. Hetta, M.Sc.
role: Principal Investigator
affiliation: Al-Azhar University
last name: Amro M. Hetta, M.Sc.
phone: +201281283482
email: doctor.hetta@gmail.com
facility: 
country: Egypt
citation: 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: 24582522
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.
PMID: 28778283
citation: 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: 25301505
citation: 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: 26796796
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.
PMID: 27868389
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.
PMID: 11880127
citation: 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: 25439846
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.
PMID: 16009483
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. No abstract available.
PMID: 26931179
citation: 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: 27125227
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.
PMID: 26231464
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.
PMID: 26073658
responsible party type: Sponsor-Investigator
investigator affiliation: Talkha Central Hospital
investigator full name: Amro M. Hetta, M.Sc.
investigator title: Principal Investigator
mesh term: Infertility
sharing ipd: Yes
ipd description: Scientific publications and Prospective thesis of MD Degree
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
study doc: 