<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/NCT02184806</url>
  </required_header>
  <id_info>
    <org_study_id>P080802</org_study_id>
    <nct_id>NCT02184806</nct_id>
  </id_info>
  <brief_title>Autograft of Human Ovarian Tissue : Efficiency and Safety</brief_title>
  <acronym>CAROLéLISA</acronym>
  <official_title>Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence de La Biomédecine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way&#xD;
      to restore fertility is autotransplantation of ovarian tissue.&#xD;
&#xD;
      The principal purpose of this study will be to evaluate the efficiency and safety of this&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian tissue cryopreservation is a new technique for female fertility preservation before&#xD;
      gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years&#xD;
      ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments&#xD;
      and in vitro follicular growth. At the present time, none mature oocytes were obtained after&#xD;
      culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported&#xD;
      8 pregnancy and 6 life birth of healthy babies.&#xD;
&#xD;
      Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in&#xD;
      Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility&#xD;
      preservation before gonadotoxic treatment. Among them, at the present time, 180 have a&#xD;
      procreative age and in consequence, could ask for the use of their ovarian cortex.&#xD;
&#xD;
      The general aim of this protocol will be to propose to women wishing to have a baby, an&#xD;
      ovarian tissue transplantation if the patients have an premature ovarian failure.&#xD;
&#xD;
      The principal aim of this study will be to evaluate the efficiency and the safety of ovarian&#xD;
      transplantation.&#xD;
&#xD;
      Before grafting, the absence of contra- indication will be check. An informed consent will be&#xD;
      signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or&#xD;
      in heterotopic localization according to the pathology and a possible contra-indication to&#xD;
      orthotopic position.&#xD;
&#xD;
      After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI,&#xD;
      will be performed.&#xD;
&#xD;
      Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and&#xD;
      if necessary in case of orthotopic graft.&#xD;
&#xD;
      The efficiency of ovarian tissue autograft will be appreciated by the delay before the&#xD;
      recovery of the ovarian function, the oocyte and embryos qualities in case of ART.&#xD;
&#xD;
      Finally, the number of pregnancies and live births will be also appreciated as well as a&#xD;
      possible recurrence of the pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2010</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>N/A</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>Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function</measure>
    <time_frame>every month after graft, up to 18 months</time_frame>
    <description>FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function</measure>
    <time_frame>every month after graft, up to 18 months</time_frame>
    <description>Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graft vascularization</measure>
    <time_frame>every month up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse of the pathology</measure>
    <time_frame>every month up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay and quality of the ovarian function recovery between ortho and heterotopic graft</measure>
    <time_frame>after ovarian function recovery, up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ovarian fragments necessary for ovarian function recovery</measure>
    <time_frame>up to 18 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ovarian Tissue Transplantation</condition>
  <arm_group>
    <arm_group_label>1- orthotopic graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>2- heterotopic graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>orthotopic graft</intervention_name>
    <description>(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or</description>
    <arm_group_label>1- orthotopic graft</arm_group_label>
    <other_name>ovarian tissue autotransplantation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>heterotopic graft</intervention_name>
    <description>put under the skin&#xD;
the ovarian fragments can be put under the skin of the abdomen</description>
    <arm_group_label>2- heterotopic graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  adult women (age ≥ 18 years old) who stored ovarian fragments before gonadotoxic&#xD;
             treatments&#xD;
&#xD;
          -  Women who desire to conceive&#xD;
&#xD;
          -  Married women or in stable couple&#xD;
&#xD;
          -  Cured women or in remission&#xD;
&#xD;
          -  Women suffering of Premature ovarian failure&#xD;
&#xD;
          -  Consenting women&#xD;
&#xD;
          -  women with health insurance&#xD;
&#xD;
        Exclusion criteria :&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  women with normal ovarian function&#xD;
&#xD;
          -  women with a disease at high risk for ovarian metastasis&#xD;
&#xD;
          -  women with contraindication for surgery&#xD;
&#xD;
          -  women with contraindication for pregnancy&#xD;
&#xD;
          -  not cured women or not in remission&#xD;
&#xD;
          -  women without health insurance&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poirot Catherine, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Poirot Catherine, MD, PhD</last_name>
    <phone>+33 1 56 01 78 00</phone>
    <email>Catherine.poirot@tnn.aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Tenon, service de Biologie de la reproduction</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Poirot Catherine, MD, PhD</last_name>
      <phone>+33 1 56 01 78 00</phone>
      <email>Catherine.poirot@tnn.aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>June 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>November 3, 2017</last_update_submitted>
  <last_update_submitted_qc>November 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian tissue transplantation</keyword>
  <keyword>Cryopreserved ovarian tissue</keyword>
  <!-- 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/NCT02184806
org study id: P080802
nct id: NCT02184806
lead sponsor: 
collaborator: 
has dmc: No
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way
      to restore fertility is autotransplantation of ovarian tissue.

      The principal purpose of this study will be to evaluate the efficiency and safety of this
      procedure.
Ovarian tissue cryopreservation is a new technique for female fertility preservation before
      gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years
      ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments
      and in vitro follicular growth. At the present time, none mature oocytes were obtained after
      culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported
      8 pregnancy and 6 life birth of healthy babies.

      Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in
      Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility
      preservation before gonadotoxic treatment. Among them, at the present time, 180 have a
      procreative age and in consequence, could ask for the use of their ovarian cortex.

      The general aim of this protocol will be to propose to women wishing to have a baby, an
      ovarian tissue transplantation if the patients have an premature ovarian failure.

      The principal aim of this study will be to evaluate the efficiency and the safety of ovarian
      transplantation.

      Before grafting, the absence of contra- indication will be check. An informed consent will be
      signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or
      in heterotopic localization according to the pathology and a possible contra-indication to
      orthotopic position.

      After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI,
      will be performed.

      Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and
      if necessary in case of orthotopic graft.

      The efficiency of ovarian tissue autograft will be appreciated by the delay before the
      recovery of the ovarian function, the oocyte and embryos qualities in case of ART.

      Finally, the number of pregnancies and live births will be also appreciated as well as a
      possible recurrence of the pathology.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
time frame: every month after graft, up to 18 months
description: FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months
measure: Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
time frame: every month after graft, up to 18 months
description: Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months
measure: Graft vascularization
time frame: every month up to 18 months
measure: Relapse of the pathology
time frame: every month up to 18 months
measure: Delay and quality of the ovarian function recovery between ortho and heterotopic graft
time frame: after ovarian function recovery, up to 18 months
measure: Number of ovarian fragments necessary for ovarian function recovery
time frame: up to 18 months
arm group label: 1- orthotopic graft
arm group type: Experimental
arm group label: 2- heterotopic graft
arm group type: Experimental
intervention type: Procedure
intervention name: orthotopic graft
description: (1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
arm group label: 1- orthotopic graft
other name: ovarian tissue autotransplantation
intervention type: Procedure
intervention name: heterotopic graft
description: put under the skin
the ovarian fragments can be put under the skin of the abdomen
arm group label: 2- heterotopic graft
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Poirot Catherine, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Poirot Catherine, MD, PhD
phone: +33 1 56 01 78 00
email: Catherine.poirot@tnn.aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor