<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/NCT03237312</url>
  </required_header>
  <id_info>
    <org_study_id>AMH-PCOS</org_study_id>
    <nct_id>NCT03237312</nct_id>
  </id_info>
  <brief_title>Serum Anti-mullerian Hormone and Polycystic Ovarian Syndrome</brief_title>
  <official_title>The Impact of Serum Antimullerian Hormone Level on Adjusting the Number of Ovarian Drills in Polycystic Ovarian 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>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>
      In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological&#xD;
      appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity.&#xD;
      At that time wedge resection of the ovaries was introduced on an empirical basis and proved a&#xD;
      successful treatment for the associated anovulation and infertility. In the ensuing fifty&#xD;
      years the limitations of a purely surgical approach to therapy have become recognized and the&#xD;
      importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary&#xD;
      Syndrome: The prevalence of polycystic ovary syndrome in any specified population is&#xD;
      dependent upon the diagnostic criteria used, but does have some regional and ethnic&#xD;
      variation. While most reports on the prevalence of polycystic ovary syndrome range between 2&#xD;
      and 20%, the chosen diagnostic criteria are recognized to influence the determined&#xD;
      prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to&#xD;
      decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been&#xD;
      done to use the level of anti-mullerian hormone as a factor for planning the number of&#xD;
      ovarian drills in each ovary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">November 30, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2016</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Size of ovarian follicle (mm)</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antimullerian hormone level (ng/dl)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ovarian volume (ml)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Four punctures in each ovary were done regardless of the level of antimullerian hormone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The study group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The number of ovarian drills was adjusted according to antimullerian hormone level</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic ovarian drilling</intervention_name>
    <description>The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.</description>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_label>The study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Antimullerian hormone</intervention_name>
    <description>In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.&#xD;
In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.</description>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_label>The study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infertility more than 2 years.&#xD;
&#xD;
          2. Age between 20-35 years.&#xD;
&#xD;
          3. clomiphene resistant patients: Patients received clomiphene 150 mg from day 3 to 7 of&#xD;
             the menstrual cycle for 6 months and non-ovulatory (with failure of conception). They&#xD;
             were followed up in the outpatient clinic.&#xD;
&#xD;
          4. No contraindications for laparoscopy.&#xD;
&#xD;
          5. Normal Hysterosalpingography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications for laparoscopy e.g cardiac diseases, bad scared abdomen ect….&#xD;
&#xD;
          2. Women's age less than 20 years or more than 35 years.&#xD;
&#xD;
          3. Previous Laparoscopic surgery.&#xD;
&#xD;
          4. Previous ovarian surgery.&#xD;
&#xD;
          5. Women with Antimullerian hormone level less than 4 ng/ml.&#xD;
&#xD;
          6. Tubal factor infertility as diagnosed by Hysterosalpingography .&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</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>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</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/NCT03237312
org study id: AMH-PCOS
nct id: NCT03237312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In 1935 the polycystic ovary syndrome was a clinical diagnosis made on the morphological
      appearance of the ovaries in association with amenorrhoea, hirsutism and frequently obesity.
      At that time wedge resection of the ovaries was introduced on an empirical basis and proved a
      successful treatment for the associated anovulation and infertility. In the ensuing fifty
      years the limitations of a purely surgical approach to therapy have become recognized and the
      importance of the biochemical abnormalities appreciated. Prevalence of polycystic Ovary
      Syndrome: The prevalence of polycystic ovary syndrome in any specified population is
      dependent upon the diagnostic criteria used, but does have some regional and ethnic
      variation. While most reports on the prevalence of polycystic ovary syndrome range between 2
      and 20%, the chosen diagnostic criteria are recognized to influence the determined
      prevalence. Anti-mullerian hormone which is a predictor of ovarian reserve is known to
      decrease after laparoscopic ovarian drilling. On the best of our knowledge no study had been
      done to use the level of anti-mullerian hormone as a factor for planning the number of
      ovarian drills in each ovary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Size of ovarian follicle (mm)
time frame: 14 days
measure: Antimullerian hormone level (ng/dl)
time frame: 3 months
measure: Ovarian volume (ml)
time frame: 3 months
arm group label: The control group
arm group type: Other
description: Four punctures in each ovary were done regardless of the level of antimullerian hormone
arm group label: The study group
arm group type: Other
description: The number of ovarian drills was adjusted according to antimullerian hormone level
intervention type: Procedure
intervention name: Laparoscopic ovarian drilling
description: The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.
arm group label: The control group
arm group label: The study group
intervention type: Biological
intervention name: Antimullerian hormone
description: In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.
In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed.
arm group label: The control group
arm group label: The study group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Dr
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Hormones
sharing ipd: Undecided