xml: <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/NCT05982236</url>
    </required_header>
    <id_info>
      <org_study_id>2022_0685</org_study_id>
      <nct_id>NCT05982236</nct_id>
    </id_info>
    <brief_title>The Psychological and Social Impact of PCOS</brief_title>
    <acronym>SPICE</acronym>
    <official_title>The Psychological and Social Impact of PCOS</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>
        The aim of the study is to assess the association between the quality of life of patients&#xD;
        with PCOS and various factors (age, BMI, socio-professional category, delay in diagnostic of&#xD;
        PCOS, infertility, hyperandrogenism, parity, history of anxiety and depression, cycles&#xD;
        disorders). This study will be proposed to patients known to have PCOS, during a follow-up&#xD;
        consultation or a visit to a day hospital in the Gynaecology Department and/or a consultation&#xD;
        in the Reproductive Medicine Department. No-objection forms will be collected at the same&#xD;
        time. A link will be sent by e-mail to the patient to access the online questionnaire on the&#xD;
        WEPI software and complete it after the consultation. Responses to the questionnaire will be&#xD;
        collected progressively and stored in a secure RedCAP file.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2023</start_date>
    <completion_date type="Anticipated">April 7, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 7, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score</measure>
      <time_frame>Day of inclusion</time_frame>
      <description>according to predefined factors (age, BMI, socio-professional category, delay in diagnosis of Polycystic Ovary Syndrome, infertility, hyperandrogenism, parity, history of anxiety and depression, cycle disorders). Mininum score: 35, maximum score: 245, A higher score means best result</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors</measure>
      <time_frame>Day of inclusion</time_frame>
      <description>minimun: 0 maximum: 42. A higher score means worse result</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors</measure>
      <time_frame>Day of inclusion</time_frame>
      <description>minimun: 0 maximum: 28 A higher score means worse result</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors</measure>
      <time_frame>Day of inclusion</time_frame>
      <description>minimun: 0 maximum: 30. A higher score means better result</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Polycystic Ovary Syndrome</condition>
    <arm_group>
      <arm_group_label>PCOS patients</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>Questionnaire on WEPI software (secure data), with link sent by e-mail to patients included in the study, including PCOSQOL, HADS, FACT G7 et ASEX scores.</description>
      <arm_group_label>PCOS patients</arm_group_label>
      <other_name>Questionnaire on WEPI</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with PCOS&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female sex&#xD;
  &#xD;
            -  Adult patient (aged 18 or over)&#xD;
  &#xD;
            -  Able to read and write in French&#xD;
  &#xD;
            -  diagnosed at a previous consultation as having PCOS according to the Rotterdam&#xD;
               criteria (at least 2 out of 3 criteria from:&#xD;
  &#xD;
                 -  Clinical signs of hyperandrogenism (hirsutism, acne, androgenic alopecia) and/or&#xD;
                    biochemical signs of hyperandrogenism (total testosterone &gt; 0.39 ng/mL and/or&#xD;
                    androstenedione &gt; 1.75 ng/mL)&#xD;
  &#xD;
                 -  Ovulation disorders (infertility, oligomenorrhoea or amenorrhoea or cycle length&#xD;
                    either &lt;21 days or &gt;35 days),&#xD;
  &#xD;
                 -  Polymicrocystic ovaries on ultrasound (either 19 or more follicles measuring 2-9&#xD;
                    mm in diameter and/or increased ovarian volume (&gt;10 cm3) and/or increased ovarian&#xD;
                    area (&gt; 5.5 cm²) without presence of cyst or dominant follicle.)&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient with no health insurance cover&#xD;
  &#xD;
            -  Difficulties understanding or speaking French&#xD;
  &#xD;
            -  Computer (tablet/smartphone) and internet connection required.&#xD;
  &#xD;
            -  Refusal to take part in research&#xD;
  &#xD;
            -  Under court protection (guardianship/curatorship/privation of liberty)&#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_contact>
      <last_name>Aramatoulaye Sambou</last_name>
      <phone>0033 320444145</phone>
      <email>drc@chru-lille.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU de Lille Hôpital Jeanne de Flandre</name>
        <address>
          <city>Lille</city>
          <state>Nord</state>
          <zip>59000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sophie Catteau-Jonard, MD</last_name>
      </contact>
      <investigator>
        <last_name>Sophie Catteau-Jonard, md</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982236
  org study id: 2022_0685
  nct id: NCT05982236
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to assess the association between the quality of life of patients
        with PCOS and various factors (age, BMI, socio-professional category, delay in diagnostic of
        PCOS, infertility, hyperandrogenism, parity, history of anxiety and depression, cycles
        disorders). This study will be proposed to patients known to have PCOS, during a follow-up
        consultation or a visit to a day hospital in the Gynaecology Department and/or a consultation
        in the Reproductive Medicine Department. No-objection forms will be collected at the same
        time. A link will be sent by e-mail to the patient to access the online questionnaire on the
        WEPI software and complete it after the consultation. Responses to the questionnaire will be
        collected progressively and stored in a secure RedCAP file.
  observational model: Case-Only
  time perspective: Prospective
  measure: Assessment to the The Polycystic Ovary Syndrome Quality of Life scale questionnaire score
  time frame: Day of inclusion
  description: according to predefined factors (age, BMI, socio-professional category, delay in diagnosis of Polycystic Ovary Syndrome, infertility, hyperandrogenism, parity, history of anxiety and depression, cycle disorders). Mininum score: 35, maximum score: 245, A higher score means best result
  measure: Assessment of the Hospital Anxiety and Depression Scale (HADS) questionnaire score according to predefined factors
  time frame: Day of inclusion
  description: minimun: 0 maximum: 42. A higher score means worse result
  measure: Assessment of the functional Assessment of Cancer Therapy-General (FACT G7) score according to predefined factors
  time frame: Day of inclusion
  description: minimun: 0 maximum: 28 A higher score means worse result
  measure: Assessment of the Arizona Sexual Experience Scale (ASEX) score according to predefined factors
  time frame: Day of inclusion
  description: minimun: 0 maximum: 30. A higher score means better result
  arm group label: PCOS patients
  intervention type: Other
  intervention name: Questionnaire
  description: Questionnaire on WEPI software (secure data), with link sent by e-mail to patients included in the study, including PCOSQOL, HADS, FACT G7 et ASEX scores.
  arm group label: PCOS patients
  other name: Questionnaire on WEPI
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aramatoulaye Sambou
  phone: 0033 320444145
  email: drc@chru-lille.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Polycystic Ovary Syndrome
  sharing ipd: No