<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/NCT04415359</url>
  </required_header>
  <id_info>
    <org_study_id>7789</org_study_id>
    <nct_id>NCT04415359</nct_id>
  </id_info>
  <brief_title>Evaluation of the Evolution of Pregnancies in the First Trimester Following MAR Management During a COVD-19 Pandemic Period</brief_title>
  <acronym>AMPCOVID-19</acronym>
  <official_title>Evaluation of the Evolution of Pregnancies in the First Trimester Following a Medically Assisted Procreation (MAR) Management During a COVD-19 Pandemic Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Because of the physiological changes inherent in pregnancy, pregnant women with lower&#xD;
      respiratory tract infections often have more worrisome outcomes compared to non-pregnant&#xD;
      individuals, including a higher rate of hospital and intensive care unit admissions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period</measure>
    <time_frame>12th week of Amenorrhea</time_frame>
  </primary_outcome>
  <enrollment type="Actual">700</enrollment>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient included in MAR protocol aged between 18 and 43 years of age who has already signed&#xD;
        a consent to management&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient included in a Medically Assisted Procreation (MAR) protocol aged between 18&#xD;
             and 43 years of age&#xD;
&#xD;
          -  Patient who has already signed a consent to management&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who expressed opposition to participating in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Service Clinico biologique d'Assistance Médicale à La Procréation</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>March 30, 2021</last_update_submitted>
  <last_update_submitted_qc>March 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>ARDS</keyword>
  <keyword>ICU</keyword>
  <keyword>Pregnant women</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Fetus</keyword>
  <keyword>Middle East Respiratory Syndrome</keyword>
  <keyword>MERS</keyword>
  <keyword>Maternal respiratory impairment</keyword>
  <keyword>Medical Assisted Procreation</keyword>
  <keyword>MAR</keyword>
  <keyword>Frozen embryos</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04415359
org study id: 7789
nct id: NCT04415359
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Because of the physiological changes inherent in pregnancy, pregnant women with lower
      respiratory tract infections often have more worrisome outcomes compared to non-pregnant
      individuals, including a higher rate of hospital and intensive care unit admissions.
observational model: Case-Only
time perspective: Other
measure: Study of the evolution of pregnancies in the first trimester following MAR management during a COVD-19 pandemic period
time frame: 12th week of Amenorrhea
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19