<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/NCT04496869</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0577</org_study_id>
    <nct_id>NCT04496869</nct_id>
  </id_info>
  <brief_title>Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment</brief_title>
  <acronym>PsyCovART</acronym>
  <official_title>Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment, a French Cohort</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>
      In France, one couple in eight encounters difficulties to conceive. The diagnosis of&#xD;
      infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to&#xD;
      be higher than in the general population.&#xD;
&#xD;
      Some recent studies have looked at the relationship between anxiety and depression in ART&#xD;
      cares.&#xD;
&#xD;
      Results are controversial, but it appears that patients with lower levels of anxiety and&#xD;
      depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms&#xD;
      of anxiety and depression than men.&#xD;
&#xD;
      First epidemiological studies related to the COVID 19 pandemic have shown strong&#xD;
      psychological impact on the general population with an anxiety rate estimated at more than&#xD;
      30%.&#xD;
&#xD;
      With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of&#xD;
      anxiety or even depression may have appeared or worsened in women undergoing infertility&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">August 31, 2020</completion_date>
  <primary_completion_date type="Actual">August 31, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Psychological impact assessed by scores of PSS10 scales.</measure>
    <time_frame>baseline</time_frame>
    <description>Perceived Stress Scale 10 assess stress in 10 questions with score from 0 to 40. The higher the score is, the more important the stress level is.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychological impact assessed by scores of HADS scales.</measure>
    <time_frame>baseline</time_frame>
    <description>depression Scale with 14 questions. It assesses separately anxiety (score from 0 to 21) and depression (score from 0 to 21).The higher the score is, the more important the anxiety level is.</description>
  </primary_outcome>
  <enrollment type="Actual">435</enrollment>
  <condition>Infertility Treatment</condition>
  <condition>Women</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online questionnaire</intervention_name>
    <description>the investigators sent by email a Googleform online questionnaires to women followed in ART center of HFME (Hospital Femme-Mère-Enfant) . Questions are about demographic characteristics, ART history, feeling during the lockdown. To evaluate psychological impact, the investigators use PSS10 and HADS scales. Both scales are worldwide validated and used in recent COVID19's research. the investigators add some quantitative questions about de feeling during the look down, ART interruption, pregnancy desire.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women between 18 and 42 years and 12 months, followed in the infertility Center of Femme&#xD;
        Mère Enfant Hospital (HFME - Bron - France).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consulting the center between 01/01/2020 to 12/31/2020&#xD;
&#xD;
          -  Email address in the medical records&#xD;
&#xD;
          -  All causes of infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women followed for:&#xD;
&#xD;
          -  Preservation of fertility&#xD;
&#xD;
          -  Oocyte donation&#xD;
&#xD;
          -  Women who do not speak or read French&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</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 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychological response</keyword>
  <keyword>infertility treatment</keyword>
  <keyword>lockdown period</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT04496869
org study id: 69HCL20_0577
nct id: NCT04496869
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In France, one couple in eight encounters difficulties to conceive. The diagnosis of
      infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to
      be higher than in the general population.

      Some recent studies have looked at the relationship between anxiety and depression in ART
      cares.

      Results are controversial, but it appears that patients with lower levels of anxiety and
      depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms
      of anxiety and depression than men.

      First epidemiological studies related to the COVID 19 pandemic have shown strong
      psychological impact on the general population with an anxiety rate estimated at more than
      30%.

      With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of
      anxiety or even depression may have appeared or worsened in women undergoing infertility
      treatment.
observational model: Cohort
time perspective: Retrospective
measure: Psychological impact assessed by scores of PSS10 scales.
time frame: baseline
description: Perceived Stress Scale 10 assess stress in 10 questions with score from 0 to 40. The higher the score is, the more important the stress level is.
measure: Psychological impact assessed by scores of HADS scales.
time frame: baseline
description: depression Scale with 14 questions. It assesses separately anxiety (score from 0 to 21) and depression (score from 0 to 21).The higher the score is, the more important the anxiety level is.
intervention type: Other
intervention name: Online questionnaire
description: the investigators sent by email a Googleform online questionnaires to women followed in ART center of HFME (Hospital Femme-Mère-Enfant) . Questions are about demographic characteristics, ART history, feeling during the lockdown. To evaluate psychological impact, the investigators use PSS10 and HADS scales. Both scales are worldwide validated and used in recent COVID19's research. the investigators add some quantitative questions about de feeling during the look down, ART interruption, pregnancy desire.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Infertility