<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/NCT03767569</url>
  </required_header>
  <id_info>
    <org_study_id>Gynositol.2018</org_study_id>
    <nct_id>NCT03767569</nct_id>
  </id_info>
  <brief_title>Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients</brief_title>
  <official_title>Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</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>
      A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower&#xD;
      testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing&#xD;
      ART&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum testosterone level after 12 weeks of administration of Myo-Inositol</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of mature oocytes</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Embryo quality</measure>
    <time_frame>2 years</time_frame>
    <description>Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate (%)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate (%)</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate in fresh cycle</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative live birth rate after 1 cycle</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ovarian Hyperstimulation Syndrome rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of gonadotrophins</measure>
    <time_frame>2 years</time_frame>
    <description>measurement in IU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stimulation days</measure>
    <time_frame>2 years</time_frame>
    <description>measurement in days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>PCOS</condition>
  <condition>Female Infertility</condition>
  <arm_group>
    <arm_group_label>Myo-inositol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Folic acid</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Folic acid 0.4 mg daily during 12 weeks before start of ART</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Myo-inositol</intervention_name>
    <description>Myo-inositol and Folic acid daily</description>
    <arm_group_label>Myo-inositol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Folic Acid</intervention_name>
    <description>Folic Acid daily</description>
    <arm_group_label>Folic acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-40 years&#xD;
&#xD;
          -  PCOS phenotypes A, B and C&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other relevant endocrine disorders&#xD;
&#xD;
          -  Contraindications to the use of gonadotropins&#xD;
&#xD;
          -  Endometriosis grade 3-4&#xD;
&#xD;
          -  BMI &gt; 35&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michel De Vos, PhD</last_name>
    <phone>+3224776699</phone>
    <email>michel.devos@uzbrussel.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sylvie De Rijdt, MD</last_name>
    <email>sylvie.derijdt@uzbrussel.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michel De Vos, PhD</last_name>
      <phone>+3224776699</phone>
      <email>michel.devos@uzbrussel.be</email>
    </contact>
    <contact_backup>
      <last_name>Sylvie De Rijdt, MD</last_name>
      <email>sylvie.derijdt@uzbrussel.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>April 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</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>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Inositol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03767569
org study id: Gynositol.2018
nct id: NCT03767569
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower
      testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing
      ART
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Serum testosterone level after 12 weeks of administration of Myo-Inositol
time frame: 2 years
measure: Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol
time frame: 2 years
measure: Number of mature oocytes
time frame: 2 years
measure: Embryo quality
time frame: 2 years
description: Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999).
measure: Implantation rate (%)
time frame: 2 years
measure: Clinical pregnancy rate (%)
time frame: 2 years
measure: Live birth rate in fresh cycle
time frame: 2 years
measure: Cumulative live birth rate after 1 cycle
time frame: 2 years
measure: Ovarian Hyperstimulation Syndrome rate
time frame: 2 years
measure: Consumption of gonadotrophins
time frame: 2 years
description: measurement in IU
measure: Stimulation days
time frame: 2 years
description: measurement in days
arm group label: Myo-inositol
arm group type: Experimental
description: Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)
arm group label: Folic acid
arm group type: Other
description: Folic acid 0.4 mg daily during 12 weeks before start of ART
intervention type: Drug
intervention name: Myo-inositol
description: Myo-inositol and Folic acid daily
arm group label: Myo-inositol
intervention type: Drug
intervention name: Folic Acid
description: Folic Acid daily
arm group label: Folic acid
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Michel De Vos, PhD
phone: +3224776699
email: michel.devos@uzbrussel.be
last name: Sylvie De Rijdt, MD
email: sylvie.derijdt@uzbrussel.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Folic Acid
mesh term: Inositol
sharing ipd: Undecided