<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/NCT03009838</url>
  </required_header>
  <id_info>
    <org_study_id>LEVOD</org_study_id>
    <nct_id>NCT03009838</nct_id>
  </id_info>
  <brief_title>Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome</brief_title>
  <official_title>Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate&#xD;
      is the most commonly used oral agent for ovulation induction in this group, but there are&#xD;
      some drawbacks with the use of it.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The ovulation rate</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mid-cyclic endometrial thickness</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>letrozole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparoscopic drilling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Letrozole</intervention_name>
    <description>oral tablets 2.5 mg</description>
    <arm_group_label>letrozole</arm_group_label>
    <other_name>femara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ovarian drilling</intervention_name>
    <description>laparoscopic electrocauterization</description>
    <arm_group_label>laparoscopic drilling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of at least one year of infertility either primary or secondary.&#xD;
&#xD;
          -  Body mass index: 25-35&#xD;
&#xD;
          -  Normal fallopian tubes&#xD;
&#xD;
          -  Normal semen analysis of the husband&#xD;
&#xD;
          -  Women who will accept to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index above 35&#xD;
&#xD;
          -  Contraindication to general anesthesia&#xD;
&#xD;
          -  Previous laparoscopic drilling&#xD;
&#xD;
          -  Presence of other causes of infertility&#xD;
&#xD;
          -  Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal&#xD;
             drugs during the preceding 6 months&#xD;
&#xD;
          -  Women who intended to start a diet program&#xD;
&#xD;
          -  Women who will refuse to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmed Abbas, MD</last_name>
    <phone>00201003385183</phone>
    <email>bmr90@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Abbas, MD</last_name>
      <phone>00201003385183</phone>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 6, 2022</last_update_submitted>
  <last_update_submitted_qc>May 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Mohamed Abbas</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Letrozole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03009838
org study id: LEVOD
nct id: NCT03009838
lead sponsor: 
has dmc: Yes
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate
      is the most commonly used oral agent for ovulation induction in this group, but there are
      some drawbacks with the use of it.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The ovulation rate
time frame: 3 months
measure: The mid-cyclic endometrial thickness
time frame: one day
arm group label: letrozole
arm group type: Active Comparator
description: letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day
arm group label: laparoscopic drilling
arm group type: Active Comparator
description: laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle
intervention type: Drug
intervention name: Letrozole
description: oral tablets 2.5 mg
arm group label: letrozole
other name: femara
intervention type: Procedure
intervention name: ovarian drilling
description: laparoscopic electrocauterization
arm group label: laparoscopic drilling
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Ahmed Abbas, MD
phone: 00201003385183
email: bmr90@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: Dr.
mesh term: Polycystic Ovary Syndrome
mesh term: Infertility
mesh term: Letrozole
sharing ipd: Yes