<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/NCT03831659</url>
  </required_header>
  <id_info>
    <org_study_id>APHP180064</org_study_id>
    <nct_id>NCT03831659</nct_id>
  </id_info>
  <brief_title>Migraine and Infertility</brief_title>
  <acronym>FERTIMIG</acronym>
  <official_title>Prevalence of Migraine in Infertile Women and Evolution During in Vitro Fertilization (IVF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The purpose of this study is to determine the prevalence of migraine in infertile women and&#xD;
      during in Vitro Fertilization protocol. Migraine is two to three times as common in women as&#xD;
      in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has&#xD;
      become a common therapeutic modality in modern fertility medicines. Treatment protocols are&#xD;
      associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely&#xD;
      linked to migraine and its fluctuations have been considered to trigger migrainous headaches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Vitro Fertilization has become a common therapeutic modality in modern fertility&#xD;
      medicines. Treatment protocols are associated with exaggerated hormonal fluctuations.&#xD;
      Estrogen is considered to be closely linked to migraine and its fluctuations have been&#xD;
      considered to trigger migrainous headaches.&#xD;
&#xD;
      Both migraine and infertility are associated with impaired quality of life.&#xD;
&#xD;
      Objectives: to assess the prevalence of migraine in infertile women and during in Vitro&#xD;
      Fertilization protocol in order to improve the management of these patients.&#xD;
&#xD;
      Protocol:&#xD;
&#xD;
      Women coming to consult at the Port Royal infertility center and meeting the inclusion&#xD;
      (infertile women without long-term analgesic treatment) criteria will be offered the study.&#xD;
      The information note and no objection form will be given by the gynecologist receiving them&#xD;
      for consultation. After collecting their non-opposition, a self-questionnaire will be given&#xD;
      to them. This questionnaire is validated in the literature concerning the diagnosis of&#xD;
      migraine. It includes questions about medical history and possible headaches. The patient&#xD;
      fills it immediately and gives it to the investigator. As part of the usual management, and&#xD;
      regardless of their answers to the questionnaire, some of the patients will be reviewed in&#xD;
      consultation for the programming of an IVF. During this &quot;incoming&quot; consultation with one of&#xD;
      the midwives of the unit, a schedule of migraine headaches will be given to the patients.&#xD;
      They will keep it, will complete it in case of migraine, and will give it to the gynecologist&#xD;
      during the embryo transfer or the doctor receiving the couple in consultation on day 7 in&#xD;
      case of absence of embryo transfer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2019</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 26, 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>migraine</measure>
    <time_frame>At inclusion</time_frame>
    <description>Prevalence of migrainous in infertile women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>migraine</measure>
    <time_frame>At 2 months</time_frame>
    <description>Prevalence of migrainous in infertile women</description>
  </secondary_outcome>
  <enrollment type="Actual">137</enrollment>
  <condition>Migraine</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>self-questionnaires</intervention_name>
    <description>After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Unit of assisted reproductive medicine in a University hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infertile women supported in reproductive medical assistance at the Port Royal&#xD;
             infertility center&#xD;
&#xD;
          -  aged between 18 and 40 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  long-term analgesic treatment&#xD;
&#xD;
          -  women under guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Port-Royal</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine</keyword>
  <keyword>in vitro fertilization</keyword>
  <keyword>infertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03831659
org study id: APHP180064
nct id: NCT03831659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the prevalence of migraine in infertile women and
      during in Vitro Fertilization protocol. Migraine is two to three times as common in women as
      in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has
      become a common therapeutic modality in modern fertility medicines. Treatment protocols are
      associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely
      linked to migraine and its fluctuations have been considered to trigger migrainous headaches.
In Vitro Fertilization has become a common therapeutic modality in modern fertility
      medicines. Treatment protocols are associated with exaggerated hormonal fluctuations.
      Estrogen is considered to be closely linked to migraine and its fluctuations have been
      considered to trigger migrainous headaches.

      Both migraine and infertility are associated with impaired quality of life.

      Objectives: to assess the prevalence of migraine in infertile women and during in Vitro
      Fertilization protocol in order to improve the management of these patients.

      Protocol:

      Women coming to consult at the Port Royal infertility center and meeting the inclusion
      (infertile women without long-term analgesic treatment) criteria will be offered the study.
      The information note and no objection form will be given by the gynecologist receiving them
      for consultation. After collecting their non-opposition, a self-questionnaire will be given
      to them. This questionnaire is validated in the literature concerning the diagnosis of
      migraine. It includes questions about medical history and possible headaches. The patient
      fills it immediately and gives it to the investigator. As part of the usual management, and
      regardless of their answers to the questionnaire, some of the patients will be reviewed in
      consultation for the programming of an IVF. During this "incoming" consultation with one of
      the midwives of the unit, a schedule of migraine headaches will be given to the patients.
      They will keep it, will complete it in case of migraine, and will give it to the gynecologist
      during the embryo transfer or the doctor receiving the couple in consultation on day 7 in
      case of absence of embryo transfer.
observational model: Cohort
time perspective: Prospective
measure: migraine
time frame: At inclusion
description: Prevalence of migrainous in infertile women
measure: migraine
time frame: At 2 months
description: Prevalence of migrainous in infertile women
intervention type: Other
intervention name: self-questionnaires
description: After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: No