<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/NCT02221154</url>
  </required_header>
  <id_info>
    <org_study_id>CHD 096-13</org_study_id>
    <nct_id>NCT02221154</nct_id>
  </id_info>
  <brief_title>Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)</brief_title>
  <acronym>FIV-INOPK</acronym>
  <official_title>Use of Myo-inositol as Adjuvant Therapy in Patients With Polycystic Ovary Syndrome (PCOS) in Vitro Fertilization (IVF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Departemental Vendee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Departemental Vendee</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The original mechanism of action of myo-inositol and preliminary results available in the&#xD;
      literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the&#xD;
      risk of OHSS in PCOS patients.&#xD;
&#xD;
      The aim of the study is to demonstrate that administration of myo-inositol decreases the&#xD;
      incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS&#xD;
      supported in IVF patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty recruiting&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 22, 2017</completion_date>
  <primary_completion_date type="Actual">May 22, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations</measure>
    <time_frame>3 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>Inofolic®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard ovarian stimulation and Inofolic®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gonadotropins;Folic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard ovarian stimulation without Inofolic®</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Inofolic®</intervention_name>
    <arm_group_label>Inofolic®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gonadotropins; Folic Acid</intervention_name>
    <description>standard ovarian stimulation</description>
    <arm_group_label>Gonadotropins;Folic Acid</arm_group_label>
    <arm_group_label>Inofolic®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients PCOS (Rotterdam ESHRE / ASRM criteria)&#xD;
&#xD;
        Combination of at least two of the following three criteria:&#xD;
&#xD;
          -  Cycle disorder&#xD;
&#xD;
          -  Clinical hyperandrogenism and / or biological&#xD;
&#xD;
          -  Account antral follicles&gt; 24&#xD;
&#xD;
          -  Age ≤ 18 ≤ 38 years&#xD;
&#xD;
          -  BMI &lt;35 kg / m²&#xD;
&#xD;
          -  Able to understand the protocol and signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not having the Rotterdam criteria&#xD;
&#xD;
          -  Patients&gt; 38 years and / or BMI&gt; 35 kg / m²&#xD;
&#xD;
          -  Woman enjoying a measure of legal protection&#xD;
&#xD;
          -  Hypersensitivity to any component of the Inofolic (myo-inositol, soy, folic acid,&#xD;
             glycerol, gelatin, coloring E171)&#xD;
&#xD;
          -  Participation in another interventional biomedical research with treatment&#xD;
             administered may disrupt ovarian stimulation&#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>Fabienne DELAY, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHD Vendée La Roche sur Yon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHI de Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Saint Nazaire</name>
      <address>
        <city>Saint Nazaire</city>
        <zip>44606</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>June 15, 2017</last_update_submitted>
  <last_update_submitted_qc>June 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>in vitro fertilization</keyword>
  <keyword>ovarian hyperstimulation</keyword>
  <keyword>pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
  </intervention_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/NCT02221154
org study id: CHD 096-13
nct id: NCT02221154
lead sponsor: 
has dmc: Yes
The original mechanism of action of myo-inositol and preliminary results available in the
      literature on its use in IVF suggest its value as adjuvant gonadotropin therapy to reduce the
      risk of OHSS in PCOS patients.

      The aim of the study is to demonstrate that administration of myo-inositol decreases the
      incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk infertile with PCOS
      supported in IVF patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Incidence of OHSS in each group, graded mild, moderate or severe based on the recommendations
time frame: 3 month
arm group label: Inofolic®
arm group type: Experimental
description: standard ovarian stimulation and Inofolic®
arm group label: Gonadotropins;Folic Acid
arm group type: Active Comparator
description: standard ovarian stimulation without Inofolic®
intervention type: Dietary Supplement
intervention name: Inofolic®
arm group label: Inofolic®
intervention type: Other
intervention name: Gonadotropins; Folic Acid
description: standard ovarian stimulation
arm group label: Gonadotropins;Folic Acid
arm group label: Inofolic®
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Fabienne DELAY, PH
role: Principal Investigator
affiliation: CHD Vendée La Roche sur Yon
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Folic Acid