<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/NCT01668225</url>
  </required_header>
  <id_info>
    <org_study_id>OVO-11-02</org_study_id>
    <nct_id>NCT01668225</nct_id>
  </id_info>
  <brief_title>Impact of Follicular and Blood G-CSF During a Natural Cycle of IVF</brief_title>
  <acronym>GCSFnat</acronym>
  <official_title>Impact of Follicular and Blood G-CSF on Pregnangcy and Implantation Rate During Modified Natural in Vitro Fertility Cycle</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>
      Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of&#xD;
      this molecule is increasing in reproduction pathology. High level of follicular and blood&#xD;
      G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation&#xD;
      rates.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Serum and / or follicular minimum level of G-CSF predictive of pregnancy</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>G-CSF FIV nat</arm_group_label>
    <description>Patient following a natural In Vitro Fecondation cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood test</intervention_name>
    <description>Taking blood sample of the patient during the day 3, triggering day, oocyte collection day and pregnancy test day.&#xD;
Taking the follicular fluid during the oocyte collection day</description>
    <arm_group_label>G-CSF FIV nat</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum sample Follicular fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with a natural cycle of an In Vitro Fecondation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women between 18 and 43 years old&#xD;
&#xD;
          -  Women natural In Vitro Fecondation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques Kadoch, 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>September 2022</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>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</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/NCT01668225
org study id: OVO-11-02
nct id: NCT01668225
lead sponsor: 
has dmc: No
Recently, scientists look into G-CSF (Granulocyte - Colony Stimulatin Factor). The use of
      this molecule is increasing in reproduction pathology. High level of follicular and blood
      G-CSF on the day of oocyte retrieval could correlate with higher pregnancy and implantation
      rates.
observational model: Case-Only
time perspective: Prospective
measure: Serum and / or follicular minimum level of G-CSF predictive of pregnancy
time frame: 6 months
arm group label: G-CSF FIV nat
description: Patient following a natural In Vitro Fecondation cycle
intervention type: Procedure
intervention name: Blood test
description: Taking blood sample of the patient during the day 3, triggering day, oocyte collection day and pregnancy test day.
Taking the follicular fluid during the oocyte collection day
arm group label: G-CSF FIV nat
Serum sample Follicular fluid
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
last name: Jacques Kadoch, MD
role: Principal Investigator
affiliation: Clinique Ovo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infertility