<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/NCT01693289</url>
  </required_header>
  <id_info>
    <org_study_id>elsharkwy t</org_study_id>
    <nct_id>NCT01693289</nct_id>
  </id_info>
  <brief_title>Study to Compare Between Combimed Metformin-letrozole and Ovarian Drilling in Pcos With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome</brief_title>
  <official_title>Phase 1 Study of Efficacy of Combined Metformin-letrozole in Comparison With Bilateral Ovarian Drilling in Clomiphene-resistant Infertile Women With Polycystic Ovarian Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <brief_summary>
    <textblock>
      the study compare the hormonal-metabolic and reproductive outcome between combined&#xD;
      metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic&#xD;
      syndrome&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hormonal and metabolic changes</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>reproductive outcome</measure>
    <time_frame>6months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Focus of Study</condition>
  <arm_group>
    <arm_group_label>Metformin plus letrozole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ovarian drilling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bilateral diathermy ovarian drilling, four drills each ovary</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metformin plus letrozole</intervention_name>
    <arm_group_label>Metformin plus letrozole</arm_group_label>
    <other_name>cidophage plus fumara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ovarian drilling</intervention_name>
    <arm_group_label>ovarian drilling</arm_group_label>
    <other_name>ovarian dithermy drilling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  polycystic ovary syndrome&#xD;
&#xD;
          -  infertility&#xD;
&#xD;
          -  clomiphene citrate resistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with other causes of infertility as male factor or tubal factor, those with&#xD;
             endocrine disorders as thyroid dysfunction and hyperprolactinemia women who received&#xD;
             hormonal treatment or ovulation induction drugs 3 months prior to the study&#xD;
&#xD;
          -  pregnancy during follow up&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 25, 2012</last_update_submitted>
  <last_update_submitted_qc>September 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>IBRAHIM ABD ELGAFOR</investigator_full_name>
    <investigator_title>obstetrics and gynecology department</investigator_title>
  </responsible_party>
  <keyword>Metformin</keyword>
  <keyword>letrozole</keyword>
  <keyword>ovarian drilling</keyword>
  <keyword>clomiphene resistance</keyword>
  <keyword>polycystic ovary.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Letrozole</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>October 2, 2012</submitted>
    <returned>October 30, 2012</returned>
    <submitted>November 6, 2012</submitted>
    <returned>December 3, 2012</returned>
  </pending_results>
  <!-- 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/NCT01693289
org study id: elsharkwy t
nct id: NCT01693289
lead sponsor: 
the study compare the hormonal-metabolic and reproductive outcome between combined
      metformin-letrozole and ovarian drilling in clomiphene resistant women with polycystic
      syndrome
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: hormonal and metabolic changes
time frame: 6 months
measure: reproductive outcome
time frame: 6months
arm group label: Metformin plus letrozole
arm group type: Experimental
description: metformin :850mg tablets twice daily for 6 months letrozole :5mg tablets twice daily form day 3to7 of cycle
arm group label: ovarian drilling
arm group type: Experimental
description: bilateral diathermy ovarian drilling, four drills each ovary
intervention type: Drug
intervention name: metformin plus letrozole
arm group label: Metformin plus letrozole
other name: cidophage plus fumara
intervention type: Procedure
intervention name: ovarian drilling
arm group label: ovarian drilling
other name: ovarian dithermy drilling
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: IBRAHIM ABD ELGAFOR
investigator title: obstetrics and gynecology department
mesh term: Polycystic Ovary Syndrome
mesh term: Metformin
mesh term: Letrozole
submitted: October 2, 2012
returned: October 30, 2012
submitted: November 6, 2012
returned: December 3, 2012