<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/NCT03241329</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A01163-50</org_study_id>
    <nct_id>NCT03241329</nct_id>
  </id_info>
  <brief_title>Endometriosis Impact on Oocyte Quality</brief_title>
  <acronym>EndOvo</acronym>
  <official_title>Characterization of Normal and Pathological Oocyte Cohort After Controlled Ovarian Stimulation: Example of Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and&#xD;
      oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the&#xD;
      follicular fluid. This evaluation will be completed by a transcriptomic analysis from the&#xD;
      cumulus cells of the oocyte.&#xD;
&#xD;
      The normal and pathological oocyte cohort after controlled ovarian stimulation will be also&#xD;
      characterized by identifying the oocyte leading to live birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endometriosis pathophysiology remains under controversy. Among the various issues raised,&#xD;
      that of his involvement in an implantation failure related to an alteration of the&#xD;
      endometrium is advanced by some authors. For others, infertility would be linked to an&#xD;
      alteration of the oocyte quality responsible for embryonic development impairment leading to&#xD;
      a lack of implantation. Several research groups have also mentioned the association of the&#xD;
      two mechanisms.&#xD;
&#xD;
      The oocyte quality evaluation is also subject to controversy. Indeed, its morphological&#xD;
      approach remains the most commonly used in routine at the IVF laboratory. However, this tool&#xD;
      remains limited and to date, no correlation between oocyte morphology and ART outcomes have&#xD;
      been established. In this context, there is a real need to use functional approaches such as&#xD;
      genomics, transcriptomics, proteomics and metabolomics. However, the clinical validation and&#xD;
      application of these functional tools have to be evaluated from a human pathology model such&#xD;
      as endometriosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 26, 2018</start_date>
  <completion_date type="Anticipated">November 12, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 12, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic profile</measure>
    <time_frame>2 years</time_frame>
    <description>Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transcriptomic profile</measure>
    <time_frame>2 years</time_frame>
    <description>Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oocyte characterization</measure>
    <time_frame>2 years</time_frame>
    <description>Identification of a possible transcriptomic profile from the cumulus cells of the oocyte which could be predictive of live birth. Search of correlations between these profiles and (i) oocyte and embryo morphology and (ii) clinical and neonatal outcomes after embryo transfer.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Case : endometriosis</arm_group_label>
    <description>Infertile patients with endometriosis that is the only cause of their infertility</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control : tubal factor</arm_group_label>
    <description>infertile patients with tubal factor that is the only cause of their infertility</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. Samples without DNA : follicular fluids&#xD;
&#xD;
        2. Samples with DNA : cumulus cells from which RNA will be extracted in order to perform&#xD;
           transcriptomics analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients enrolled in a ART (assisted reproductive technology) attempt in the IVF unit of&#xD;
        the center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Group 1: case&#xD;
&#xD;
        a. Womens with endometriosis i. Deep endometriosis without ovarian localisation ii. Deep&#xD;
        endometriosis associated with ovarian localisation iii. Isolated ovarian localisation b.&#xD;
        Male partner with normal sperm parameters Group 2 : control&#xD;
&#xD;
          1. Womens with isolated tubal factor&#xD;
&#xD;
          2. Male partner with normal sperm parameters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other pathologies responsible for female infertility&#xD;
&#xD;
          -  Altered sperm parameters&#xD;
&#xD;
          -  Male or female viral risk&#xD;
&#xD;
          -  Oocyte or sperm donation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khaled POCATE-CHERIET, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Khaled POCATE-CHERIET, MD, PhD</last_name>
    <phone>+33 1 58 41 37 00</phone>
    <email>khaled.pocate@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie Benhammani-Godard</last_name>
    <phone>+33 1 58 41 11 90</phone>
    <email>marie.godard@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Cochin-Port Royal</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Khaled POCATE-CHERIET, MD, PhD</last_name>
      <phone>+33 1 58 41 37 27</phone>
      <email>khaled.pocate@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 12, 2021</last_update_submitted>
  <last_update_submitted_qc>July 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>Metabolomics</keyword>
  <keyword>Transcriptomics</keyword>
  <keyword>Follicular fluid</keyword>
  <keyword>Cumulus cells</keyword>
  <keyword>Oocyte quality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03241329
org study id: 2017-A01163-50
nct id: NCT03241329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and
      oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the
      follicular fluid. This evaluation will be completed by a transcriptomic analysis from the
      cumulus cells of the oocyte.

      The normal and pathological oocyte cohort after controlled ovarian stimulation will be also
      characterized by identifying the oocyte leading to live birth.
Endometriosis pathophysiology remains under controversy. Among the various issues raised,
      that of his involvement in an implantation failure related to an alteration of the
      endometrium is advanced by some authors. For others, infertility would be linked to an
      alteration of the oocyte quality responsible for embryonic development impairment leading to
      a lack of implantation. Several research groups have also mentioned the association of the
      two mechanisms.

      The oocyte quality evaluation is also subject to controversy. Indeed, its morphological
      approach remains the most commonly used in routine at the IVF laboratory. However, this tool
      remains limited and to date, no correlation between oocyte morphology and ART outcomes have
      been established. In this context, there is a real need to use functional approaches such as
      genomics, transcriptomics, proteomics and metabolomics. However, the clinical validation and
      application of these functional tools have to be evaluated from a human pathology model such
      as endometriosis.
observational model: Case-Control
time perspective: Prospective
measure: Metabolic profile
time frame: 2 years
description: Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis
measure: Transcriptomic profile
time frame: 2 years
description: Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis
measure: Oocyte characterization
time frame: 2 years
description: Identification of a possible transcriptomic profile from the cumulus cells of the oocyte which could be predictive of live birth. Search of correlations between these profiles and (i) oocyte and embryo morphology and (ii) clinical and neonatal outcomes after embryo transfer.
arm group label: Case : endometriosis
description: Infertile patients with endometriosis that is the only cause of their infertility
arm group label: Control : tubal factor
description: infertile patients with tubal factor that is the only cause of their infertility
1. Samples without DNA : follicular fluids

        2. Samples with DNA : cumulus cells from which RNA will be extracted in order to perform
           transcriptomics analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Khaled POCATE-CHERIET, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Khaled POCATE-CHERIET, MD, PhD
phone: +33 1 58 41 37 00
email: khaled.pocate@aphp.fr
last name: Marie Benhammani-Godard
phone: +33 1 58 41 11 90
email: marie.godard@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: No