<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/NCT04426942</url>
  </required_header>
  <id_info>
    <org_study_id>2019PI2016</org_study_id>
    <nct_id>NCT04426942</nct_id>
  </id_info>
  <brief_title>Sexuality in Medically Assisted Procreation Pregnancies</brief_title>
  <official_title>Evaluation of the Couple's Sexuality During a Pregnancy Resulting From Medically Assisted Procreation and Comparison With Sexuality During a Spontaneous Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</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>
      We wish to evaluate sexuality during pregnancy between spontaneous pregnancies and resulting&#xD;
      from assisted procreation The literature is poor on thie subject&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 20, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of sexual functioning with Female Sexual Function Index (FSFI) test</measure>
    <time_frame>In the second trimester of the pregnancy</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Assisted Reproduction</condition>
  <arm_group>
    <arm_group_label>Spontaneous pregnancy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Assisted reproduction pregnancy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey</intervention_name>
    <description>survey on sexuality during pregnancy</description>
    <arm_group_label>Assisted reproduction pregnancy</arm_group_label>
    <arm_group_label>Spontaneous pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physiological pregnancy&#xD;
&#xD;
          -  pregnancy from assisted reproduction&#xD;
&#xD;
          -  age over 18&#xD;
&#xD;
          -  to understand french&#xD;
&#xD;
          -  patient's agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pathological pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Matthieu Dap</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthieu Dap</last_name>
      <phone>0630736896</phone>
      <email>m.dap@chru-nancy.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
    <investigator_full_name>Matthieu DAP</investigator_full_name>
    <investigator_title>Docteur</investigator_title>
  </responsible_party>
  <keyword>assisted reproduction</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04426942
org study id: 2019PI2016
nct id: NCT04426942
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We wish to evaluate sexuality during pregnancy between spontaneous pregnancies and resulting
      from assisted procreation The literature is poor on thie subject
observational model: Cohort
time perspective: Prospective
measure: Evaluation of sexual functioning with Female Sexual Function Index (FSFI) test
time frame: In the second trimester of the pregnancy
arm group label: Spontaneous pregnancy
arm group label: Assisted reproduction pregnancy
intervention type: Other
intervention name: survey
description: survey on sexuality during pregnancy
arm group label: Assisted reproduction pregnancy
arm group label: Spontaneous pregnancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: N/A
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Central Hospital, Nancy, France
investigator full name: Matthieu DAP
investigator title: Docteur
sharing ipd: Undecided