<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/NCT01718340</url>
  </required_header>
  <id_info>
    <org_study_id>MetRPL</org_study_id>
    <nct_id>NCT01718340</nct_id>
  </id_info>
  <brief_title>Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia</brief_title>
  <acronym>MetRPL</acronym>
  <official_title>Phase 4 Study of Effectiveness of Metformin in Patients With Unexplained Recurrent Miscarriages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of insulin resistance is increased in women with recurrent miscarriage&#xD;
      compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only&#xD;
      implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical&#xD;
      complications during pregnancy.An elevated free androgen index appears to be a prognostic&#xD;
      factor for a subsequent miscarriage in women with recurrent miscarriage.&#xD;
&#xD;
      There is insufficient evidence to evaluate the effect of metformin supplementation in&#xD;
      pregnancy to prevent a miscarriage in women with recurrent miscarriage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients with PCO and hyper insulinemia will be subdivided into two groups, one group&#xD;
      will continue metformin 500 mg three times per day from the start of induction of ovulation&#xD;
      till the end of pregnancy, the other group will stop the drug once pregnancy test become&#xD;
      positive. Pregnancy follow up including the early and second trimester pregnancy loss,&#xD;
      Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine&#xD;
      growth restriction were also analyzed at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS</measure>
    <time_frame>2 ys</time_frame>
    <description>The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study and any fetal malformation</measure>
    <time_frame>2 ys</time_frame>
    <description>The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Abortion, Habitual</condition>
  <arm_group>
    <arm_group_label>Metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>metformin tablet 500mg three time per day</description>
    <arm_group_label>Metformin</arm_group_label>
    <other_name>glucophage</other_name>
    <other_name>cidophage</other_name>
    <other_name>amophage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women who are diagnosed to have PCOS and/or haven hyper insulinaemia and have a&#xD;
             previous history of recurrent miscarriages.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patients with PCOS or hyper insulinaemia previously treated by any forms of&#xD;
             insulin sensitizers.&#xD;
&#xD;
        Age above forty years old .&#xD;
&#xD;
          -  Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG&#xD;
             or IgM]); other recognised thrombophilic conditions (testing according to usual clinic&#xD;
             practice).&#xD;
&#xD;
          -  Intrauterine abnormalities (as assessed by ultrasound, hysterosonography,&#xD;
             hysterosalpingogram, or hysteroscopy).&#xD;
&#xD;
          -  Fibroids distorting uterine cavity .&#xD;
&#xD;
          -  Abnormal parental karyotype .&#xD;
&#xD;
          -  Other identifiable causes of recurrent miscarriages (tests initiated only if&#xD;
             clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus&#xD;
             (SLE).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa M Ismail, M D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of medicine,Assiut university,Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Women's Health Hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>alaa eldeen mahmoud ismail</investigator_full_name>
    <investigator_title>M D</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>Hyper insulinaemia</keyword>
  <keyword>metformin</keyword>
  <keyword>recurrent abortion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Habitual</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</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/NCT01718340
org study id: MetRPL
nct id: NCT01718340
lead sponsor: 
has dmc: Yes
The prevalence of insulin resistance is increased in women with recurrent miscarriage
      compared with matched fertile controls,Insulin resistance (IR) in this syndrome is not only
      implicated toward early pregnancy loss (EPL) but also pathognomic for various obstetrical
      complications during pregnancy.An elevated free androgen index appears to be a prognostic
      factor for a subsequent miscarriage in women with recurrent miscarriage.

      There is insufficient evidence to evaluate the effect of metformin supplementation in
      pregnancy to prevent a miscarriage in women with recurrent miscarriage.
The patients with PCO and hyper insulinemia will be subdivided into two groups, one group
      will continue metformin 500 mg three times per day from the start of induction of ovulation
      till the end of pregnancy, the other group will stop the drug once pregnancy test become
      positive. Pregnancy follow up including the early and second trimester pregnancy loss,
      Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine
      growth restriction were also analyzed at the end of the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double
measure: The primary outcome is to evaluate the clinical pregnancy rate and the effectiveness of Metformin in the reduction of EPL in women with PCOS
time frame: 2 ys
description: The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy,
measure: Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study and any fetal malformation
time frame: 2 ys
description: The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive. Pregnancy follow up including the early and second trimester pregnancy loss, Secondary outcomes like gestational diabetes, pregnancy-induced hypertension and intrauterine growth restriction were also analyzed at the end of the study.
arm group label: Metformin
arm group type: Experimental
description: The patients with PCO and hyper insulinemia will be subdivided into two groups, one group will continue metformin 500 mg three times per day from the start of induction of ovulation till the end of pregnancy, the other group will stop the drug once pregnancy test become positive
intervention type: Drug
intervention name: Metformin
description: metformin tablet 500mg three time per day
arm group label: Metformin
other name: glucophage
other name: cidophage
other name: amophage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alaa M Ismail, M D
role: Principal Investigator
affiliation: Faculty of medicine,Assiut university,Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: alaa eldeen mahmoud ismail
investigator title: M D
mesh term: Abortion, Spontaneous
mesh term: Abortion, Habitual
mesh term: Metformin