<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/NCT04461899</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0002</org_study_id>
    <secondary_id>2020-A00118-31</secondary_id>
    <nct_id>NCT04461899</nct_id>
  </id_info>
  <brief_title>Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy</brief_title>
  <acronym>ENDOPAL AMH</acronym>
  <official_title>Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with&#xD;
      three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep&#xD;
      pelvic endometriosis (subperitoneal).&#xD;
&#xD;
      Surgical management of endometriomas is justified in cases of significant clinical symptoms&#xD;
      (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic&#xD;
      cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is&#xD;
      now well demonstrated that this surgery significantly reduces the ovarian reserve.&#xD;
&#xD;
      Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas.&#xD;
      Several studies demonstrated the effectiveness and safety of this treatment, particularly in&#xD;
      terms of preserving fertility. Regarding these reassuring data, many clinicians changed their&#xD;
      practices and propose this technique as a first-line surgery.&#xD;
&#xD;
      Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of&#xD;
      the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.&#xD;
&#xD;
      The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy.&#xD;
      This study is conducted in the Hospices Civils de Lyon, in 3 different sites.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">October 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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AMH level</measure>
    <time_frame>3 months (+/-15 days) after endometrioma sclerotherapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AMH level</measure>
    <time_frame>12 months (+/-15 days) after endometrioma sclerotherapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AMH level</measure>
    <time_frame>12 months after endometrioma sclerotherapy</time_frame>
    <description>AMH level 3 and 12 months after endometrioma sclerotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometrioma recurrence</measure>
    <time_frame>3 months (+/-15 days) after endometrioma sclerotherapy</time_frame>
    <description>New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endometrioma recurrence</measure>
    <time_frame>12 months (+/-15 days) after endometrioma sclerotherapy</time_frame>
    <description>New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">53</enrollment>
  <condition>Endometriosis Ovary</condition>
  <arm_group>
    <arm_group_label>sclerotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>a sclerotherapy will be done in patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.</description>
    <arm_group_label>sclerotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient in childbearing age from 18 to 42 years.&#xD;
&#xD;
          -  Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound&#xD;
             criteria for ovarian carcinoma.&#xD;
&#xD;
          -  A sclerotherapy is programmed.&#xD;
&#xD;
          -  Patient affiliated to a social security scheme.&#xD;
&#xD;
          -  Patient who gave consent for this research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  doubt about the endometriotic origin of the cyst&#xD;
&#xD;
          -  suspect malignant ovarian disease.&#xD;
&#xD;
          -  Pregnant or breastfeeding patient.&#xD;
&#xD;
          -  Patient participating in other research with an exclusion period still in progress at&#xD;
             the time of inclusion or those included in interventional research that interferes&#xD;
             with the study protocol.&#xD;
&#xD;
          -  Patient deprived of liberty by judicial or administrative decision.&#xD;
&#xD;
          -  Patient (≥ 18 years old) under legal protection or unable to give consent.&#xD;
&#xD;
          -  Patient does not speak French.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gil DUBERNARD, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gil DUBERNARD, Pr</last_name>
    <phone>4 72 07 16 37</phone>
    <phone_ext>+33</phone_ext>
    <email>gil.dubernard@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sophie WAREMBOURG, Dr</last_name>
    <phone>4 72 07 19 36</phone>
    <phone_ext>+33</phone_ext>
    <email>sophie.warembourg@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bruno SALLE, Pr</last_name>
      <phone>4 72 12 94 12</phone>
      <phone_ext>+33</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gil DUBERNARD, Pr</last_name>
      <phone>4 72 07 16 37</phone>
      <phone_ext>+33</phone_ext>
      <email>gil.dubernard@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François GOLFIER, Pr</last_name>
      <phone>4.78.86.41.79</phone>
      <phone_ext>+33</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endometrioma</keyword>
  <keyword>sclerotherapy</keyword>
  <keyword>ovarian reserve</keyword>
  <keyword>antimüllerian hormone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04461899
org study id: 69HCL20_0002
secondary id: 2020-A00118-31
nct id: NCT04461899
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with
      three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep
      pelvic endometriosis (subperitoneal).

      Surgical management of endometriomas is justified in cases of significant clinical symptoms
      (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic
      cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is
      now well demonstrated that this surgery significantly reduces the ovarian reserve.

      Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas.
      Several studies demonstrated the effectiveness and safety of this treatment, particularly in
      terms of preserving fertility. Regarding these reassuring data, many clinicians changed their
      practices and propose this technique as a first-line surgery.

      Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of
      the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.

      The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy.
      This study is conducted in the Hospices Civils de Lyon, in 3 different sites.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: AMH level
time frame: 3 months (+/-15 days) after endometrioma sclerotherapy
measure: AMH level
time frame: 12 months (+/-15 days) after endometrioma sclerotherapy
measure: AMH level
time frame: 12 months after endometrioma sclerotherapy
description: AMH level 3 and 12 months after endometrioma sclerotherapy
measure: Endometrioma recurrence
time frame: 3 months (+/-15 days) after endometrioma sclerotherapy
description: New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
measure: Endometrioma recurrence
time frame: 12 months (+/-15 days) after endometrioma sclerotherapy
description: New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple
arm group label: sclerotherapy
arm group type: Other
description: a sclerotherapy will be done in patients
intervention type: Biological
intervention name: Blood test
description: additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.
arm group label: sclerotherapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Gil DUBERNARD, Pr
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Gil DUBERNARD, Pr
phone: 4 72 07 16 37
phone ext: +33
email: gil.dubernard@chu-lyon.fr
last name: Sophie WAREMBOURG, Dr
phone: 4 72 07 19 36
phone ext: +33
email: sophie.warembourg@chu-lyon.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Endometriosis