<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/NCT01668212</url>
  </required_header>
  <id_info>
    <org_study_id>OVO-11-01</org_study_id>
    <nct_id>NCT01668212</nct_id>
  </id_info>
  <brief_title>Perifollicular Doppler in Natural Cycle In Vitro Fertilization</brief_title>
  <official_title>Perifollicular Doppler in Natural Cycle In Vitro Fertilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Ovo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Ovo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perifollicular Doppler could reflect the quality of the follicle's vascularization and,&#xD;
      consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the&#xD;
      analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.&#xD;
&#xD;
      The goal of this study is to evaluate if there is a link, in natural cycle In Vitro&#xD;
      Fertilization, between the quality of the vascularization and the one of the oocyte, the&#xD;
      embryo and the pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <primary_completion_date type="Actual">May 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality perifollicular doppler and quality of the oocyte</measure>
    <time_frame>2 weeks</time_frame>
    <description>The measurements are done twice; on days of induction and oocyte retrieval. During the blood sample collection on the day of the induction, there is also a measurement of progesterone, estradiol and luteinizing hormone (LH).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>natural In Vitro Fertilization cycle</arm_group_label>
    <description>Patient doing following natural In Vitro fertilization cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Doppler ultrasound</intervention_name>
    <description>Doppler Ultrasound</description>
    <arm_group_label>natural In Vitro Fertilization cycle</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women following In Vitro Fertilization cycle&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with a natural In Vitro Fertilization cycle.&#xD;
&#xD;
          -  Patient under 38 years old&#xD;
&#xD;
          -  Body mass indice under 35&#xD;
&#xD;
          -  Ovulatory cycles between 20-35 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a stimulation In Vitro Fertilization cycle&#xD;
&#xD;
          -  Patient with a naturalIn Vitro Fertilization cycle with egg donor&#xD;
&#xD;
          -  Patient with a natural In Vitro Fertilization cycle with freezing embryo&#xD;
&#xD;
          -  Smoking patient&#xD;
&#xD;
          -  Diabetic patient&#xD;
&#xD;
          -  Patient with treatment of antihypertensive drug, anticoagulant, antiplatelet,&#xD;
             vasodilator&#xD;
&#xD;
          -  Body mass indice over 35&#xD;
&#xD;
          -  Patient over 38 years old&#xD;
&#xD;
          -  Patient without ovulation or cycle over 35 days&#xD;
&#xD;
          -  Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE) or&#xD;
             micro TESE&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Delphine Delrieu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Ovo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ovo Fertilité</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4P 2S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>June 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>June 21, 2013</last_update_submitted>
  <last_update_submitted_qc>June 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</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/NCT01668212
org study id: OVO-11-01
nct id: NCT01668212
lead sponsor: 
has dmc: No
Perifollicular Doppler could reflect the quality of the follicle's vascularization and,
      consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the
      analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.

      The goal of this study is to evaluate if there is a link, in natural cycle In Vitro
      Fertilization, between the quality of the vascularization and the one of the oocyte, the
      embryo and the pregnancy.
observational model: Case-Only
time perspective: Prospective
measure: Quality perifollicular doppler and quality of the oocyte
time frame: 2 weeks
description: The measurements are done twice; on days of induction and oocyte retrieval. During the blood sample collection on the day of the induction, there is also a measurement of progesterone, estradiol and luteinizing hormone (LH).
arm group label: natural In Vitro Fertilization cycle
description: Patient doing following natural In Vitro fertilization cycle
intervention type: Procedure
intervention name: Doppler ultrasound
description: Doppler Ultrasound
arm group label: natural In Vitro Fertilization cycle
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Delphine Delrieu, MD
role: Principal Investigator
affiliation: Clinique Ovo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infertility