<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/NCT03241472</url>
  </required_header>
  <id_info>
    <org_study_id>NACLET</org_study_id>
    <nct_id>NCT03241472</nct_id>
  </id_info>
  <brief_title>Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole</brief_title>
  <official_title>Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole</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>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>
      Infertility is defined as a couple's inability to become pregnant after one year of&#xD;
      unprotected intercourse in women 35 years old and younger, and for six months in women over&#xD;
      age 35 years. In any given year, about 15 percent of couples in North America and Europe who&#xD;
      are trying to conceive are infertile&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>rate of ovulation</measure>
    <time_frame>3 months</time_frame>
    <description>ultrasound evaluation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Lertozole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral tablets 5 mg start from third day cycle for 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clomiphene plus N- acetyl cystiene</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Letrozole</intervention_name>
    <description>oral tablets 5 mg</description>
    <arm_group_label>Lertozole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clomiphene Citrate plus N acetyl cystine</intervention_name>
    <description>Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg</description>
    <arm_group_label>clomiphene plus N- acetyl cystiene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All primary and secondary. Infertility due to anovulation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male factor infertility, tubal factor.&#xD;
&#xD;
          -  Endocrineopathy&#xD;
&#xD;
          -  Hypothyrodism&#xD;
&#xD;
          -  Morbid obesity&#xD;
&#xD;
          -  Under weight&#xD;
&#xD;
          -  Patient with previous surgery including drilling of ovary, Clomiphene Citrate&#xD;
             resistant to ovulation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</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>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>
    <mesh_term>Clomiphene</mesh_term>
    <mesh_term>Enclomiphene</mesh_term>
    <mesh_term>Zuclomiphene</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/NCT03241472
org study id: NACLET
nct id: NCT03241472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infertility is defined as a couple's inability to become pregnant after one year of
      unprotected intercourse in women 35 years old and younger, and for six months in women over
      age 35 years. In any given year, about 15 percent of couples in North America and Europe who
      are trying to conceive are infertile
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: rate of ovulation
time frame: 3 months
description: ultrasound evaluation
arm group label: Lertozole
arm group type: Experimental
description: oral tablets 5 mg start from third day cycle for 5 days
arm group label: clomiphene plus N- acetyl cystiene
arm group type: Active Comparator
description: clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days
intervention type: Drug
intervention name: Letrozole
description: oral tablets 5 mg
arm group label: Lertozole
intervention type: Drug
intervention name: Clomiphene Citrate plus N acetyl cystine
description: Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg
arm group label: clomiphene plus N- acetyl cystiene
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Mohamed Abbas
investigator title: principal investigator
mesh term: Infertility
mesh term: Letrozole
mesh term: Clomiphene
mesh term: Enclomiphene
mesh term: Zuclomiphene
sharing ipd: Undecided