<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/NCT03823833</url>
  </required_header>
  <id_info>
    <org_study_id>2018_48</org_study_id>
    <nct_id>NCT03823833</nct_id>
  </id_info>
  <brief_title>Oocyte Freezing for Fertility Preservation in Benign Ovarian Tumors</brief_title>
  <acronym>OFBOT</acronym>
  <official_title>Systematic Proposal of Fertility Preservation by Oocyte Freezing in Case of Benign Ovarian Tumors With High Risk of Recurrence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</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>
      Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or&#xD;
      fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be&#xD;
      necessary to identify the nature of the cyst and assess its benignity. In some case, cysts&#xD;
      are recurrent and multiple surgeries are needed leading to a significant risk of ovarian&#xD;
      damage by follicular depletion. Oocyte cryopreservation is no longer considered as an&#xD;
      experimental technique of Fertility Preservation since 2013 as it has been recognized to be&#xD;
      efficient and safe. According to reproductive medicine scientific committees and the French&#xD;
      ethic law, fertility preservation has to be proposed in every situation of infertility risk.&#xD;
      To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in&#xD;
      this specific subgroup of patients. The purpose of the study is to prospectively evaluate the&#xD;
      oocyte number and quality after controlled ovarian hyperstimulation in patients with&#xD;
      recurrent ovarian cysts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of mature oocytes eligible for cryopreservation</measure>
    <time_frame>After 15 days of controlled ovarian hyperstimulation (COH)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of immature or morphologically abnormal oocytes</measure>
    <time_frame>Real-time, the day of egg retrieval</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation</measure>
    <time_frame>The day of HCG triggering at the end of ovarian stimulation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on tolerance and complications</measure>
    <time_frame>One week after the egg retrieval</time_frame>
    <description>A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometriosis</condition>
  <condition>Dermoid Cyst</condition>
  <condition>Mucinous Cyst</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Young women with benign ovarian tumors and high risk of further infertility due to surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with benign ovarian tumor with high risk of recurrence, i-e, endometrioma,&#xD;
             dermoid cysts or mucinous cysts.&#xD;
&#xD;
          -  women with previous surgery and/or high risk of ovarian damage: bilateral cysts, cyst&#xD;
             diameter higher than 5 cms&#xD;
&#xD;
          -  Having a social insurance&#xD;
&#xD;
          -  Able to give an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Borderline tumors&#xD;
&#xD;
          -  Undetectable AMH levels&#xD;
&#xD;
          -  Personal history of thrombo-embolic events&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>young women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine Decanter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine Decanter, MD</last_name>
    <phone>320445962</phone>
    <phone_ext>+33</phone_ext>
    <email>christine.decanter@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hop Jeanne de Flandre Chu Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oocyte freezing</keyword>
  <keyword>fertility preservation</keyword>
  <keyword>ovarian cysts</keyword>
  <keyword>benign ovarian tumor</keyword>
  <keyword>endometrioma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Dermoid Cyst</mesh_term>
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03823833
org study id: 2018_48
nct id: NCT03823833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Benign ovarian cysts are frequent during women's life. They are diagnosed with pelvic pain or
      fortuitously during an ultra-sonographic exam. In case of persistence,a surgery will be
      necessary to identify the nature of the cyst and assess its benignity. In some case, cysts
      are recurrent and multiple surgeries are needed leading to a significant risk of ovarian
      damage by follicular depletion. Oocyte cryopreservation is no longer considered as an
      experimental technique of Fertility Preservation since 2013 as it has been recognized to be
      efficient and safe. According to reproductive medicine scientific committees and the French
      ethic law, fertility preservation has to be proposed in every situation of infertility risk.
      To date, there is no cohort study dedicated to fertility preservation by oocyte freezing in
      this specific subgroup of patients. The purpose of the study is to prospectively evaluate the
      oocyte number and quality after controlled ovarian hyperstimulation in patients with
      recurrent ovarian cysts.
observational model: Cohort
time perspective: Prospective
measure: Number of mature oocytes eligible for cryopreservation
time frame: After 15 days of controlled ovarian hyperstimulation (COH)
measure: Percentage of immature or morphologically abnormal oocytes
time frame: Real-time, the day of egg retrieval
measure: Number of mature follicles (≥15 mm) and intermediary (10-14 mm) during ovarian stimulation
time frame: The day of HCG triggering at the end of ovarian stimulation
measure: Questionnaire on tolerance and complications
time frame: One week after the egg retrieval
description: A systematic telephone interview will be carried out 48 to 72 hours after the oocyte puncture to judge the tolerance of the procedure.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: young women
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Christine Decanter, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Christine Decanter, MD
phone: 320445962
phone ext: +33
email: christine.decanter@chru-lille.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Cysts
mesh term: Ovarian Neoplasms
mesh term: Dermoid Cyst
mesh term: Endometriosis