<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/NCT03277430</url>
  </required_header>
  <id_info>
    <org_study_id>2044/15 (NM-15-01)</org_study_id>
    <nct_id>NCT03277430</nct_id>
  </id_info>
  <brief_title>Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study</brief_title>
  <acronym>UTxLD/DBD</acronym>
  <official_title>Uterus Transplantation From Live Donors and From Deceased Donors - Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Motol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical and Experimental Medicine</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>
      Uterus transplantation (UTx) is the only causative treatment for congenital or acquired&#xD;
      uterus absence. Individual cases of UTx from a live donor (LD UTx) with healthy child birth&#xD;
      performed so far showed favourable outcomes. The present study will include both LD UTx and&#xD;
      UTx from deceased donors after brain death (DBD UTx). The aim is treatment of uterine&#xD;
      infertility by UTx. It is is an ethically justifiable life-promoting transplantation. Twenty&#xD;
      UTx will be performed in 2 parallel arms: 10 LD UTx and 10 DBD UTx. Immunosuppression will be&#xD;
      administered. Phases of the UTx procedure are: in vitro fertilization - cryopreservation of&#xD;
      embryos - uterus retrieval - UTx - follow up - embryo transfer - pregnancy - child birth -&#xD;
      later graft hysterectomy - life long follow up. Introduction of UTx into clinical practice&#xD;
      may enable women with uterine infertility to have their own children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Uterus transplantation (UTx) is the only causative treatment for congenital or&#xD;
      acquired uterus absence, i.e. absolute uterine factor infertility (AUFI). Feasibility of&#xD;
      uterus transplantation from o live donor and possibility of healthy child birth have been&#xD;
      proven in previous clinical study in Sweden. The present study is supposed to extend the&#xD;
      swedish experience by including UTx from both live donors and from deceased donors after&#xD;
      brain death.&#xD;
&#xD;
      Aim: Treatment of absolute uterine factor infertility that has no other therapy option by&#xD;
      uterus transplantation. Extending basic knowledge on UTx. Possible introduction of UTx into&#xD;
      clinical practice.&#xD;
&#xD;
      Indications: UTx can be offered to patients with congenital uterus absence - aplasia uteri et&#xD;
      vaginae, also called Mullerian aplasia or Rokitansky-Mayer-Kuster-Hauser syndrome (RMKH), in&#xD;
      whom previous neo-vagina was created. UTx can be performed also in women with acquired uterus&#xD;
      absence on the basis of previous hysterectomy e.g. for myomas, endometriosis, post-partum&#xD;
      bleeding, cervical cancer, uterus malformations or intrauterine adhesions. Ovarian function&#xD;
      must be preserved and stable male partner is required for in vitro fertilization (IVF).&#xD;
&#xD;
      Ethics: Uterus retrieval from a deceased brain-dead donor does not endanger retrieval of&#xD;
      other life-saving organs. Live donor does not loose a vitally important organ. The only&#xD;
      alternative is adoption of a child. Surrogacy is illegal in many european countries. UTx is&#xD;
      the only causative treatment of AUFI. It is is an ethically justifiable life-promoting&#xD;
      transplantation. UTx improves quality of live of both the recipient and the live donor by&#xD;
      giving an opportunity to have an own child. Board certification for this study was obtained&#xD;
      from the Ministry of Health of the Czech Republic and from the local Ethics Committee.&#xD;
&#xD;
      Methods: Twenty UTx will be performed in total in 2 parallel arms: 10 UTx from a live donor&#xD;
      (LD UTx) and 10 UTx from a deceased brain-dead donor (DBD UTx). Patients who have no suitable&#xD;
      live donor will be wait-listed for a deceased donor. Compatible blood group and negative&#xD;
      cross-match test is required. AB0 incompatible or pair exchange transplantations are also&#xD;
      possible. Donors and recipients will be examined by clinical, laboratory and imaging methods.&#xD;
      All diagnostic and therapeutic procedures will be performed according to a protocol. Risk and&#xD;
      benefit will be assessed by a multi-disciplinary team. Informed consent will be signed. Time&#xD;
      period between UTx and embryo transfer is supposed to be about 1 year depending on condition&#xD;
      of the recipient and the graft, e.g. level of immunosuppression, rejection or infection&#xD;
      episodes. Adverse events will be monitored and addressed. Number of possible pregnancies and&#xD;
      child births is estimated to be up to 2. The uterus graft will be removed in the end. Overall&#xD;
      time interval of keeping the uterus graft in situ and exposure to immunosuppressive therapy&#xD;
      is estimated to be up to 5 years.&#xD;
&#xD;
      Immunosuppression: Induction immunosuppression is based on thymoglobuline and&#xD;
      corticosteroids. Maintenance immunosuppression is based on tacrolimus, mycophenolate and&#xD;
      corticosteroids. Temporary anti-infective prophylaxis will be administered. Minimalization of&#xD;
      immunosuppression is needed before pregnancy (monotherapy with tacrolimus). Protocol cervix&#xD;
      biopsies to look for possible rejection will be performed. Immunosuppression will be&#xD;
      discontinued after graft hysterectomy.&#xD;
&#xD;
      Phases of the UTx procedure: in vitro fertilization (IVF phase I) - cryopreservation of&#xD;
      embryos - uterus retrieval from a live donor or from a deceased donor - orthotopic uterus&#xD;
      transplantation with open technique - follow up period - embryo transfer (IVF phase II) -&#xD;
      pregnancy - child birth via Cesarian section - later graft hysterectomy - life long follow&#xD;
      up.&#xD;
&#xD;
      Merit: Individual cases of uterus transplantation performed so far showed favourable&#xD;
      outcomes. Introduction of UTx into clinical practice may enable women with uterine&#xD;
      infertility to have their own children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 9, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of uterus transplantation.</measure>
    <time_frame>Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.</time_frame>
    <description>Number of successful uterus transplantations and healthy child births. Treatment of absolute uterine factor infertility that has no other therapy option by uterus transplantation that includes in vitro fertilization and cryopreservation, uterus transplantation from a live donor or from a deceased donor, graft survival on immunosuppression, embryo transfer, pregnancy and child birth, final graft hysterectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of efficacy of uterus transplantation from live donors versus deceased donors.</measure>
    <time_frame>Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.</time_frame>
    <description>Number of successful uterus transplantations and healthy child births from live donors versus deceased donors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events after uterus transplantation</measure>
    <time_frame>Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.</time_frame>
    <description>Number of recipients of uterus transplantation with adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events after live uterus donation</measure>
    <time_frame>Until 10 live donor transplants have been performed plus approximately 5 years.</time_frame>
    <description>Number of live donor participants after uterus retrieval with adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events during pregnancy and child birth after uterus transplantation</measure>
    <time_frame>Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.</time_frame>
    <description>Number of children conceived and born from transplanted uterus with adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verification of technique of uterus retrieval</measure>
    <time_frame>Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.</time_frame>
    <description>Verification of surgical technique of uterus retrieval from a live donor and from a deceased donor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Mayer Rokitansky Kuster Hauser Syndrome</condition>
  <condition>Mullerian Aplasia</condition>
  <condition>Uterus; Absence, Congenital</condition>
  <condition>Infertility, Female</condition>
  <condition>Uterus Absence, Acquired</condition>
  <condition>Absolute Uterine Factor Infertility</condition>
  <arm_group>
    <arm_group_label>Live donor uterus transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transplantation of uterus from a living donor. Immunosuppression with tacrolimus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deceased donor uterus transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Live donor uterus transplantation</intervention_name>
    <description>Transplantation of uterus from a living donor.</description>
    <arm_group_label>Live donor uterus transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deceased donor uterus transplantation</intervention_name>
    <description>Transplantation of uterus from a deceased brain-dead donor.</description>
    <arm_group_label>Deceased donor uterus transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tacrolimus</intervention_name>
    <description>Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.</description>
    <arm_group_label>Deceased donor uterus transplantation</arm_group_label>
    <arm_group_label>Live donor uterus transplantation</arm_group_label>
    <other_name>FK506</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for UTx recipient:&#xD;
&#xD;
          -  18 - 40 years of age&#xD;
&#xD;
          -  good general health&#xD;
&#xD;
          -  congenital or acquired uterus absence&#xD;
&#xD;
          -  desire for a child&#xD;
&#xD;
        Exclusion Criteria for UTx recipient:&#xD;
&#xD;
          -  age over 40&#xD;
&#xD;
          -  serious comorbidity&#xD;
&#xD;
        Inclusion Criteria for a live uterus donor:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  18 - 60 years of age&#xD;
&#xD;
          -  maximum 4 child births&#xD;
&#xD;
          -  maximum 1 Cesarian section&#xD;
&#xD;
          -  good general health&#xD;
&#xD;
        Exclusion Criteria for a live uterus donor:&#xD;
&#xD;
          -  age over 60&#xD;
&#xD;
          -  hypertension with organ damage&#xD;
&#xD;
          -  diabetes mellitus&#xD;
&#xD;
          -  other serious comorbidity&#xD;
&#xD;
        Inclusion Criteria for a deceased brain-dead uterus donor:&#xD;
&#xD;
          -  female&#xD;
&#xD;
          -  age under 60&#xD;
&#xD;
          -  no previous hysterectomy&#xD;
&#xD;
          -  no previous uterus malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiri Fronek, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jiri Fronek, Assoc Prof</last_name>
    <phone>+420 26 136 4105</phone>
    <email>jifr@ikem.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Renata Zamecnikova, Bc</last_name>
    <phone>+420 26 136 4105, 5300</phone>
    <email>zamr@ikem.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute for Clinical and Experimental Medicine</name>
      <address>
        <city>Prague</city>
        <zip>14021</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiri Fronek, Assoc Prof</last_name>
      <phone>+420 26 136 4105</phone>
      <email>jifr@ikem.cz</email>
    </contact>
    <contact_backup>
      <last_name>Renata Zamecnikova, Bc</last_name>
      <phone>+420 26 136 4105</phone>
      <email>zamr@ikem.cz</email>
    </contact_backup>
    <investigator>
      <last_name>Jiri Fronek, Assoc Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Roman Chmel, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Olausson, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <link>
    <url>http://www.ikem.cz/en/transplantcentrum/klinika-transplantacni-chirurgie/o-nas/programy/transplantace-delohy/a-2460/</url>
    <description>Uterine transplantation in the Czech Republic, description and contacts</description>
  </link>
  <reference>
    <citation>Erman Akar M, Ozekinci M, Alper O, Demir D, Cevikol C, Meric Bilekdemir A, Daloglu A, Ongut G, Senol Y, Ozdem S, Uzun G, Luleci G, Suleymanlar G. Assessment of women who applied for the uterine transplant project as potential candidates for uterus transplantation. J Obstet Gynaecol Res. 2015 Jan;41(1):12-6. doi: 10.1111/jog.12486. Epub 2014 Sep 17.</citation>
    <PMID>25226847</PMID>
  </reference>
  <reference>
    <citation>Olausson M, Johannesson L, Brattgard D, Diaz-Garcia C, Lundmark C, Groth K, Marcickiewizc J, Enskog A, Akouri R, Tzakis A, Rogiers X, Janson PO, Brannstrom M. Ethics of uterus transplantation with live donors. Fertil Steril. 2014 Jul;102(1):40-3. doi: 10.1016/j.fertnstert.2014.03.048. Epub 2014 Apr 28. No abstract available.</citation>
    <PMID>24784936</PMID>
  </reference>
  <reference>
    <citation>Johannesson L, Dahm-Kahler P, Eklind S, Brannstrom M. The future of human uterus transplantation. Womens Health (Lond). 2014 Jul;10(4):455-67. doi: 10.2217/whe.14.22.</citation>
    <PMID>25259905</PMID>
  </reference>
  <reference>
    <citation>Farrell RM, Falcone T. Uterine transplantation. Fertil Steril. 2014 May;101(5):1244-5. doi: 10.1016/j.fertnstert.2014.03.022. Epub 2014 Apr 13. No abstract available.</citation>
    <PMID>24726215</PMID>
  </reference>
  <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>Ozturk H. How real is the uterine transplantation? Ann Transplant. 2014 Feb 14;19:82-3. doi: 10.12659/AOT.889973. No abstract available.</citation>
    <PMID>24535028</PMID>
  </reference>
  <reference>
    <citation>Akar ME, Ozkan O, Ozekinci M, Sindel M, Yildirim F, Oguz N. Uterus retrieval in cadaver: technical aspects. Clin Exp Obstet Gynecol. 2014;41(3):293-5.</citation>
    <PMID>24992779</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Clinical and Experimental Medicine</investigator_affiliation>
    <investigator_full_name>Jiri Fronek</investigator_full_name>
    <investigator_title>MD PhD Assoc Prof</investigator_title>
  </responsible_party>
  <keyword>uterus transplantation, absolute uterine factor infertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tacrolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03277430
org study id: 2044/15 (NM-15-01)
nct id: NCT03277430
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Uterus transplantation (UTx) is the only causative treatment for congenital or acquired
      uterus absence. Individual cases of UTx from a live donor (LD UTx) with healthy child birth
      performed so far showed favourable outcomes. The present study will include both LD UTx and
      UTx from deceased donors after brain death (DBD UTx). The aim is treatment of uterine
      infertility by UTx. It is is an ethically justifiable life-promoting transplantation. Twenty
      UTx will be performed in 2 parallel arms: 10 LD UTx and 10 DBD UTx. Immunosuppression will be
      administered. Phases of the UTx procedure are: in vitro fertilization - cryopreservation of
      embryos - uterus retrieval - UTx - follow up - embryo transfer - pregnancy - child birth -
      later graft hysterectomy - life long follow up. Introduction of UTx into clinical practice
      may enable women with uterine infertility to have their own children.
Introduction: Uterus transplantation (UTx) is the only causative treatment for congenital or
      acquired uterus absence, i.e. absolute uterine factor infertility (AUFI). Feasibility of
      uterus transplantation from o live donor and possibility of healthy child birth have been
      proven in previous clinical study in Sweden. The present study is supposed to extend the
      swedish experience by including UTx from both live donors and from deceased donors after
      brain death.

      Aim: Treatment of absolute uterine factor infertility that has no other therapy option by
      uterus transplantation. Extending basic knowledge on UTx. Possible introduction of UTx into
      clinical practice.

      Indications: UTx can be offered to patients with congenital uterus absence - aplasia uteri et
      vaginae, also called Mullerian aplasia or Rokitansky-Mayer-Kuster-Hauser syndrome (RMKH), in
      whom previous neo-vagina was created. UTx can be performed also in women with acquired uterus
      absence on the basis of previous hysterectomy e.g. for myomas, endometriosis, post-partum
      bleeding, cervical cancer, uterus malformations or intrauterine adhesions. Ovarian function
      must be preserved and stable male partner is required for in vitro fertilization (IVF).

      Ethics: Uterus retrieval from a deceased brain-dead donor does not endanger retrieval of
      other life-saving organs. Live donor does not loose a vitally important organ. The only
      alternative is adoption of a child. Surrogacy is illegal in many european countries. UTx is
      the only causative treatment of AUFI. It is is an ethically justifiable life-promoting
      transplantation. UTx improves quality of live of both the recipient and the live donor by
      giving an opportunity to have an own child. Board certification for this study was obtained
      from the Ministry of Health of the Czech Republic and from the local Ethics Committee.

      Methods: Twenty UTx will be performed in total in 2 parallel arms: 10 UTx from a live donor
      (LD UTx) and 10 UTx from a deceased brain-dead donor (DBD UTx). Patients who have no suitable
      live donor will be wait-listed for a deceased donor. Compatible blood group and negative
      cross-match test is required. AB0 incompatible or pair exchange transplantations are also
      possible. Donors and recipients will be examined by clinical, laboratory and imaging methods.
      All diagnostic and therapeutic procedures will be performed according to a protocol. Risk and
      benefit will be assessed by a multi-disciplinary team. Informed consent will be signed. Time
      period between UTx and embryo transfer is supposed to be about 1 year depending on condition
      of the recipient and the graft, e.g. level of immunosuppression, rejection or infection
      episodes. Adverse events will be monitored and addressed. Number of possible pregnancies and
      child births is estimated to be up to 2. The uterus graft will be removed in the end. Overall
      time interval of keeping the uterus graft in situ and exposure to immunosuppressive therapy
      is estimated to be up to 5 years.

      Immunosuppression: Induction immunosuppression is based on thymoglobuline and
      corticosteroids. Maintenance immunosuppression is based on tacrolimus, mycophenolate and
      corticosteroids. Temporary anti-infective prophylaxis will be administered. Minimalization of
      immunosuppression is needed before pregnancy (monotherapy with tacrolimus). Protocol cervix
      biopsies to look for possible rejection will be performed. Immunosuppression will be
      discontinued after graft hysterectomy.

      Phases of the UTx procedure: in vitro fertilization (IVF phase I) - cryopreservation of
      embryos - uterus retrieval from a live donor or from a deceased donor - orthotopic uterus
      transplantation with open technique - follow up period - embryo transfer (IVF phase II) -
      pregnancy - child birth via Cesarian section - later graft hysterectomy - life long follow
      up.

      Merit: Individual cases of uterus transplantation performed so far showed favourable
      outcomes. Introduction of UTx into clinical practice may enable women with uterine
      infertility to have their own children.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of uterus transplantation.
time frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
description: Number of successful uterus transplantations and healthy child births. Treatment of absolute uterine factor infertility that has no other therapy option by uterus transplantation that includes in vitro fertilization and cryopreservation, uterus transplantation from a live donor or from a deceased donor, graft survival on immunosuppression, embryo transfer, pregnancy and child birth, final graft hysterectomy.
measure: Comparison of efficacy of uterus transplantation from live donors versus deceased donors.
time frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
description: Number of successful uterus transplantations and healthy child births from live donors versus deceased donors.
measure: Rate of adverse events after uterus transplantation
time frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
description: Number of recipients of uterus transplantation with adverse events.
measure: Rate of adverse events after live uterus donation
time frame: Until 10 live donor transplants have been performed plus approximately 5 years.
description: Number of live donor participants after uterus retrieval with adverse events.
measure: Rate of adverse events during pregnancy and child birth after uterus transplantation
time frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
description: Number of children conceived and born from transplanted uterus with adverse events.
measure: Verification of technique of uterus retrieval
time frame: Until 10 live donor and 10 deceased donor uterus transplants have been performed plus approximately 5 years.
description: Verification of surgical technique of uterus retrieval from a live donor and from a deceased donor.
arm group label: Live donor uterus transplantation
arm group type: Experimental
description: Transplantation of uterus from a living donor. Immunosuppression with tacrolimus.
arm group label: Deceased donor uterus transplantation
arm group type: Experimental
description: Transplantation of uterus from a deceased brain-dead donor. Immunosuppression with tacrolimus.
intervention type: Procedure
intervention name: Live donor uterus transplantation
description: Transplantation of uterus from a living donor.
arm group label: Live donor uterus transplantation
intervention type: Procedure
intervention name: Deceased donor uterus transplantation
description: Transplantation of uterus from a deceased brain-dead donor.
arm group label: Deceased donor uterus transplantation
intervention type: Drug
intervention name: Tacrolimus
description: Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
arm group label: Deceased donor uterus transplantation
arm group label: Live donor uterus transplantation
other name: FK506
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jiri Fronek, Assoc Prof
role: Principal Investigator
affiliation: Transplant Surgery Department, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
last name: Jiri Fronek, Assoc Prof
phone: +420 26 136 4105
email: jifr@ikem.cz
last name: Renata Zamecnikova, Bc
phone: +420 26 136 4105, 5300
email: zamr@ikem.cz
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Czechia
url: http://www.ikem.cz/en/transplantcentrum/klinika-transplantacni-chirurgie/o-nas/programy/transplantace-delohy/a-2460/
description: Uterine transplantation in the Czech Republic, description and contacts
citation: Erman Akar M, Ozekinci M, Alper O, Demir D, Cevikol C, Meric Bilekdemir A, Daloglu A, Ongut G, Senol Y, Ozdem S, Uzun G, Luleci G, Suleymanlar G. Assessment of women who applied for the uterine transplant project as potential candidates for uterus transplantation. J Obstet Gynaecol Res. 2015 Jan;41(1):12-6. doi: 10.1111/jog.12486. Epub 2014 Sep 17.
PMID: 25226847
citation: Olausson M, Johannesson L, Brattgard D, Diaz-Garcia C, Lundmark C, Groth K, Marcickiewizc J, Enskog A, Akouri R, Tzakis A, Rogiers X, Janson PO, Brannstrom M. Ethics of uterus transplantation with live donors. Fertil Steril. 2014 Jul;102(1):40-3. doi: 10.1016/j.fertnstert.2014.03.048. Epub 2014 Apr 28. No abstract available.
PMID: 24784936
citation: Johannesson L, Dahm-Kahler P, Eklind S, Brannstrom M. The future of human uterus transplantation. Womens Health (Lond). 2014 Jul;10(4):455-67. doi: 10.2217/whe.14.22.
PMID: 25259905
citation: Farrell RM, Falcone T. Uterine transplantation. Fertil Steril. 2014 May;101(5):1244-5. doi: 10.1016/j.fertnstert.2014.03.022. Epub 2014 Apr 13. No abstract available.
PMID: 24726215
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: Ozturk H. How real is the uterine transplantation? Ann Transplant. 2014 Feb 14;19:82-3. doi: 10.12659/AOT.889973. No abstract available.
PMID: 24535028
citation: Akar ME, Ozkan O, Ozekinci M, Sindel M, Yildirim F, Oguz N. Uterus retrieval in cadaver: technical aspects. Clin Exp Obstet Gynecol. 2014;41(3):293-5.
PMID: 24992779
responsible party type: Principal Investigator
investigator affiliation: Institute for Clinical and Experimental Medicine
investigator full name: Jiri Fronek
investigator title: MD PhD Assoc Prof
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Tacrolimus
sharing ipd: Undecided