<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/NCT02236780</url>
  </required_header>
  <id_info>
    <org_study_id>AOR13130</org_study_id>
    <nct_id>NCT02236780</nct_id>
  </id_info>
  <brief_title>Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies</brief_title>
  <acronym>MeteoFIV</acronym>
  <official_title>Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UPRES EA 2506 (Santé-Environnement-Vieillissement), France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the study is to assess the impact of environmental conditions on&#xD;
      live-birth rates after intraconjugal IVF.&#xD;
&#xD;
      The second purposes are&#xD;
&#xD;
        -  to assess the impact on pregnancies (prematurity, preeclampsia);&#xD;
&#xD;
        -  to assess the impact on newborn's health (stunted growth);&#xD;
&#xD;
        -  to evaluate the consistency of results observed between assisted pregnancies and&#xD;
           spontaneous pregnancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter epidemiological study aims to analyze the individual standardized clinical&#xD;
      records, collected prospectively since 2008 in the medically assisted procreation centers&#xD;
      (MAP).&#xD;
&#xD;
      These individual data will be mapped to the environmental data (meteorological and air&#xD;
      quality), recorded in the area of residence of the mother at the time of conception and&#xD;
      pregnancy, as well as to the socio-economic data.&#xD;
&#xD;
      Choice of centers:&#xD;
&#xD;
        -  The study will be proposed to the 106 private or public centers in metropolitan France&#xD;
           who are authorized for MAP procedures such as IVF and ICSI.&#xD;
&#xD;
        -  Only the centers who perform more than 200 oocyte retrievals per year will be selected&#xD;
           to participate in the study.&#xD;
&#xD;
      More than 80% of attempts performed by the selected centers should be available (without&#xD;
      missing data) on the induced pregnancies and their outcome (minimum data set for each case:&#xD;
      age of man and woman, cause of infertility, technique used, sperm collection method&#xD;
      (ejaculation, surgical sperm retrieval techniques), total number of embryos obtained,&#xD;
      clinical pregnancy or not, term of pregnancy, weight and height of the child at birth).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Live birth rate</measure>
    <time_frame>1 year</time_frame>
    <description>Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>1 year</time_frame>
    <description>Rate of fertilization (IVF and ICSI), rate of good quality embryos, rate of blastoformation (if prolonged culture), rate of embryo freezing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of clinical pregnancy</measure>
    <time_frame>1 year</time_frame>
    <description>Rates of assisted pregnancy, rate of spontaneous miscarriage, rate of medical termination of pregnancy, rate of pathology of pregnancy (pre-eclampsia, gestational diabetes, placenta praevia, signs of preterm labor with hospitalization).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal growth restriction rate</measure>
    <time_frame>1 year</time_frame>
    <description>Fetal growth restriction rate, biometrics of child at birth (height, weight, head circumference, Body Mass Index), preterm birth rate, transfer rate to intensive care units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect sizes and periods of susceptibility to environmental conditions</measure>
    <time_frame>5 years</time_frame>
    <description>Effect sizes and periods of susceptibility to environmental conditions among assisted pregnancies and spontaneous pregnancies.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">24000</enrollment>
  <condition>In Vitro Fertilisation</condition>
  <condition>Environmental Conditions</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study focuses on intraconjugal IVF attempts (conventional IVF, microinjection&#xD;
        intra-cytoplasmic sperm injection (ICSI) and frozen embryo transfers) realised for MAP&#xD;
        procedures in metropolitan France, in the period of 01/01/2008 to 12/31/2012 (5 years).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intraconjugal IVF and ICSI&#xD;
&#xD;
          -  Transfers of frozen embryos after intraconjugal IVF or ICSI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IVF and ICSI with sperm donation&#xD;
&#xD;
          -  IVF and ICSI with egg donation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alain BEAUCHET, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Ambroise Paré, AP-HP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe AEGERTER, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hôpital Ambroise Paré, AP-HP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachel LEVY, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hôpital Jean Verdier, AP-HP</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alain BEAUCHET, MD</last_name>
    <phone>+ 33 (0)1 49 09 56 68</phone>
    <email>alain.beauchet@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philippe AEGERTER, MD, PhD</last_name>
    <phone>+ 33 01 49 09 58 86</phone>
    <email>philippe.aegerter@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alain BEAUCHET</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <state>Hauts-de-seine</state>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain BEAUCHET, MD</last_name>
      <phone>+ 33 (0)1 49 09 56 68</phone>
      <email>alain.beauchet@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>November 17, 2017</last_update_submitted>
  <last_update_submitted_qc>November 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>in vitro fertilisation</keyword>
  <keyword>environmental conditions</keyword>
  <keyword>pregnancy</keyword>
  <keyword>live birth rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</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/NCT02236780
org study id: AOR13130
nct id: NCT02236780
lead sponsor: 
collaborator: 
has dmc: No
The main purpose of the study is to assess the impact of environmental conditions on
      live-birth rates after intraconjugal IVF.

      The second purposes are

        -  to assess the impact on pregnancies (prematurity, preeclampsia);

        -  to assess the impact on newborn's health (stunted growth);

        -  to evaluate the consistency of results observed between assisted pregnancies and
           spontaneous pregnancies.
This multicenter epidemiological study aims to analyze the individual standardized clinical
      records, collected prospectively since 2008 in the medically assisted procreation centers
      (MAP).

      These individual data will be mapped to the environmental data (meteorological and air
      quality), recorded in the area of residence of the mother at the time of conception and
      pregnancy, as well as to the socio-economic data.

      Choice of centers:

        -  The study will be proposed to the 106 private or public centers in metropolitan France
           who are authorized for MAP procedures such as IVF and ICSI.

        -  Only the centers who perform more than 200 oocyte retrievals per year will be selected
           to participate in the study.

      More than 80% of attempts performed by the selected centers should be available (without
      missing data) on the induced pregnancies and their outcome (minimum data set for each case:
      age of man and woman, cause of infertility, technique used, sperm collection method
      (ejaculation, surgical sperm retrieval techniques), total number of embryos obtained,
      clinical pregnancy or not, term of pregnancy, weight and height of the child at birth).
observational model: Cohort
time perspective: Retrospective
measure: Live birth rate
time frame: 1 year
description: Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.
measure: Fertilization rate
time frame: 1 year
description: Rate of fertilization (IVF and ICSI), rate of good quality embryos, rate of blastoformation (if prolonged culture), rate of embryo freezing.
measure: Rates of clinical pregnancy
time frame: 1 year
description: Rates of assisted pregnancy, rate of spontaneous miscarriage, rate of medical termination of pregnancy, rate of pathology of pregnancy (pre-eclampsia, gestational diabetes, placenta praevia, signs of preterm labor with hospitalization).
measure: Fetal growth restriction rate
time frame: 1 year
description: Fetal growth restriction rate, biometrics of child at birth (height, weight, head circumference, Body Mass Index), preterm birth rate, transfer rate to intensive care units.
measure: Effect sizes and periods of susceptibility to environmental conditions
time frame: 5 years
description: Effect sizes and periods of susceptibility to environmental conditions among assisted pregnancies and spontaneous pregnancies.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alain BEAUCHET, MD
role: Study Chair
affiliation: Hôpital Ambroise Paré, AP-HP
last name: Philippe AEGERTER, MD, PhD
role: Study Director
affiliation: Hôpital Ambroise Paré, AP-HP
last name: Rachel LEVY, MD, PhD
role: Study Director
affiliation: Hôpital Jean Verdier, AP-HP
last name: Alain BEAUCHET, MD
phone: + 33 (0)1 49 09 56 68
email: alain.beauchet@aphp.fr
last name: Philippe AEGERTER, MD, PhD
phone: + 33 01 49 09 58 86
email: philippe.aegerter@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Disease