<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/NCT02239107</url>
  </required_header>
  <id_info>
    <org_study_id>n-acetyl cysteine PCOS</org_study_id>
    <nct_id>NCT02239107</nct_id>
  </id_info>
  <brief_title>N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome</brief_title>
  <official_title>N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant 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 a major endocrinological disorder affecting 5-8% of reproductive&#xD;
      aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene&#xD;
      citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second&#xD;
      line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction.&#xD;
      Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy,&#xD;
      some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has&#xD;
      emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and&#xD;
      pregnancy rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant&#xD;
      problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted&#xD;
      second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC&#xD;
      resistant patients.&#xD;
&#xD;
      Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown&#xD;
      evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic&#xD;
      drug which has been used for various other indications including detoxification and cancer&#xD;
      chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant&#xD;
      therapy to Clomiphene citrate for induction of ovulation in resistant patients with some&#xD;
      showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was&#xD;
      addressed in a single pilot study showing good results with improved ovulation and pregnancy&#xD;
      rates compared to the non users.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>ovulation rate</measure>
    <time_frame>6 month</time_frame>
    <description>ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pregnancy rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>N-Acetyl cysteine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laparoscopic drilling group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopic drilling only will be done</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-Acetyl cysteine</intervention_name>
    <arm_group_label>N-Acetyl cysteine</arm_group_label>
    <other_name>Acetyl cysteine</other_name>
    <other_name>NAC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic ovarian drilling</intervention_name>
    <arm_group_label>N-Acetyl cysteine</arm_group_label>
    <arm_group_label>laparoscopic drilling group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PCOS patients according to Rotterdam criteria who failed to respond to 6 month&#xD;
             ovulation induction therapy with clomiphene citrate,&#xD;
&#xD;
          -  normal semen analysis of partner&#xD;
&#xD;
          -  normal tubo-peritoneal anatomy as assessed by laparoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who have other causes of infertility&#xD;
&#xD;
          -  patients receiving gonadotrophin ovulation induction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>esraa yousef badran</investigator_full_name>
    <investigator_title>Esraa yousef Badran</investigator_title>
  </responsible_party>
  <keyword>polycystic ovary syndrome</keyword>
  <keyword>laparoscopic drilling</keyword>
  <keyword>clomiphene citrate</keyword>
  <keyword>n acetyl cysteine</keyword>
  <keyword>insulin resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</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/NCT02239107
org study id: n-acetyl cysteine PCOS
nct id: NCT02239107
lead sponsor: 
has dmc: Yes
Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive
      aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene
      citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second
      line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction.
      Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy,
      some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has
      emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and
      pregnancy rate.
Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant
      problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted
      second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC
      resistant patients.

      Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown
      evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic
      drug which has been used for various other indications including detoxification and cancer
      chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant
      therapy to Clomiphene citrate for induction of ovulation in resistant patients with some
      showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was
      addressed in a single pilot study showing good results with improved ovulation and pregnancy
      rates compared to the non users.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ovulation rate
time frame: 6 month
description: ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone
measure: pregnancy rate
time frame: 2 years
arm group label: N-Acetyl cysteine
arm group type: Experimental
description: Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month
arm group label: laparoscopic drilling group
arm group type: Active Comparator
description: laparoscopic drilling only will be done
intervention type: Drug
intervention name: N-Acetyl cysteine
arm group label: N-Acetyl cysteine
other name: Acetyl cysteine
other name: NAC
intervention type: Procedure
intervention name: laparoscopic ovarian drilling
arm group label: N-Acetyl cysteine
arm group label: laparoscopic drilling group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: esraa yousef badran
investigator title: Esraa yousef Badran
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine