<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/NCT04456010</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0351</org_study_id>
    <nct_id>NCT04456010</nct_id>
  </id_info>
  <brief_title>COVID-19 in ART: Perception and Experience</brief_title>
  <acronym>COVAPEX</acronym>
  <official_title>Assessing the Perception and the Personal Experience of the COVID19 Pandemic Among Infertile Couples Undergoing Assisted Reproductive Treatment (ART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Non-urgent medical care, such as fertility treatments, has been massively postponed during&#xD;
      the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might&#xD;
      cause anxiety and depression among infertile couples, who are already exposed to the&#xD;
      distressing experience of infertility and for whom the wait for a baby already appears&#xD;
      unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and&#xD;
      foetus, or on fertility.&#xD;
&#xD;
      This study aims to assess the views of infertile couple regarding the potential risks of&#xD;
      COVID during their fertility treatment and their personal experience of the COVID pandemic&#xD;
      and their expectation for further treatment .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation</measure>
    <time_frame>1 day</time_frame>
    <description>Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk assessment</measure>
    <time_frame>1 day</time_frame>
    <description>. Risk assessment by the patient, via a survey, regarding SARS-CoV-2 during a fertility treatment or during pregnancy. Perception of the risks linked to SARS-CoV-2 during their fertility treatment or during a pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients'expectations regarding the management of an abrupt closure of the fertility center</measure>
    <time_frame>1 day</time_frame>
    <description>Patients'expectations regarding the management of an abrupt closure of the fertility center, via a survey</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>COVID19</condition>
  <condition>Fertility Issues</condition>
  <condition>ART</condition>
  <arm_group>
    <arm_group_label>Infertile couple</arm_group_label>
    <description>Infertile couple who had a fertility treatment prescribed during the past 9 months which was not completed yet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Eligible patients will be selected from our electronical database and invited via email to participate.</description>
    <arm_group_label>Infertile couple</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile couple (male and female) who had a fertility treatment prescribed during the past&#xD;
        9 months (prescription after October 1st, 2019) in the fertility department of Montpellier&#xD;
        Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Men and women who had a fertility treatment prescribed during the past 9 months in our&#xD;
        Fertility department&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient attending for a fertility preservation&#xD;
&#xD;
          -  Patient attending for a preimplantation genetic testing (PGT-M or PGT-SR)&#xD;
&#xD;
          -  Patient not fluent in French&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noémie Ranisavljevic, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fertility</keyword>
  <keyword>risk perception</keyword>
  <keyword>emotional experience</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04456010
org study id: RECHMPL20_0351
nct id: NCT04456010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Non-urgent medical care, such as fertility treatments, has been massively postponed during
      the past weeks due to the COVID19 pandemic. The lockdown and the closure of IVF centers might
      cause anxiety and depression among infertile couples, who are already exposed to the
      distressing experience of infertility and for whom the wait for a baby already appears
      unending. Few data are available regarding the impact of SARS-CoV-2 on pregnant women and
      foetus, or on fertility.

      This study aims to assess the views of infertile couple regarding the potential risks of
      COVID during their fertility treatment and their personal experience of the COVID pandemic
      and their expectation for further treatment .
observational model: Other
time perspective: Prospective
measure: Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment pandemic and the discontinuation
time frame: 1 day
description: Personal experience of the COVID19 pandemic and the discontinuation of their fertility treatment, via a survey
measure: Risk assessment
time frame: 1 day
description: . Risk assessment by the patient, via a survey, regarding SARS-CoV-2 during a fertility treatment or during pregnancy. Perception of the risks linked to SARS-CoV-2 during their fertility treatment or during a pregnancy
measure: Patients'expectations regarding the management of an abrupt closure of the fertility center
time frame: 1 day
description: Patients'expectations regarding the management of an abrupt closure of the fertility center, via a survey
arm group label: Infertile couple
description: Infertile couple who had a fertility treatment prescribed during the past 9 months which was not completed yet.
intervention type: Other
intervention name: Questionnaire
description: Eligible patients will be selected from our electronical database and invited via email to participate.
arm group label: Infertile couple
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Noémie Ranisavljevic, M.D., Ph.D
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Infertility
sharing ipd: Undecided
ipd description: NC