<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/NCT04500522</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/355/4/19</org_study_id>
    <nct_id>NCT04500522</nct_id>
  </id_info>
  <brief_title>Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients</brief_title>
  <official_title>Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To compare the effectiveness of vaginal isonicotinic acid hydrazide with placebo in&#xD;
      minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce&#xD;
      hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the&#xD;
      hysteroscopist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as&#xD;
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during&#xD;
      the removal of an intrauterine device or foreign body. Cervical ripening is made possible by&#xD;
      the use of medication through different routes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">September 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2021</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>
    <intervention_model_description>double blind randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The difference in pain scores</measure>
    <time_frame>10 minutes</time_frame>
    <description>Pain intensity will be assessed by visual analogue scale during the procedure. visual analogue scale ranging from 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity of pain</measure>
    <time_frame>30 minutes after the procedure</time_frame>
    <description>Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>15 minutes</time_frame>
    <description>From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>INH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 vaginal tablet of isonicotinic acid hydrazide (INH) 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INH</intervention_name>
    <description>3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
    <arm_group_label>INH</arm_group_label>
    <other_name>isonicotinic acid hydrazide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.</description>
    <arm_group_label>Placebo Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a&#xD;
             part of an infertility diagnosis workup&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with suspected pregnancy&#xD;
&#xD;
          -  heavy vaginal bleeding&#xD;
&#xD;
          -  recent pelvic infection&#xD;
&#xD;
          -  those known to have hypersensitivity or contraindication to isonicotinic acid&#xD;
             hydrazide&#xD;
&#xD;
          -  those who received analgesics prior to office heavy vaginal bleeding&#xD;
&#xD;
          -  recent pelvic infection&#xD;
&#xD;
          -  a concomitant neurologic disease that could affect the correct evaluation of pain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>nulliparous women with primary infertility</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>nahla w Shady, md</last_name>
    <role>Study Chair</role>
    <affiliation>Aswan universirty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aswan University Hospital</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>A Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isoniazid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04500522
org study id: aswu/355/4/19
nct id: NCT04500522
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effectiveness of vaginal isonicotinic acid hydrazide with placebo in
      minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce
      hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the
      hysteroscopist.
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as
      polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during
      the removal of an intrauterine device or foreign body. Cervical ripening is made possible by
      the use of medication through different routes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomized controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind randomized controlled trial
measure: The difference in pain scores
time frame: 10 minutes
description: Pain intensity will be assessed by visual analogue scale during the procedure. visual analogue scale ranging from 0 to 10
measure: Intensity of pain
time frame: 30 minutes after the procedure
description: Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
measure: Operative time
time frame: 15 minutes
description: From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
arm group label: INH
arm group type: Experimental
description: 3 vaginal tablet of isonicotinic acid hydrazide (INH) 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
arm group label: Placebo Comparator
arm group type: Placebo Comparator
description: 3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
intervention type: Drug
intervention name: INH
description: 3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
arm group label: INH
other name: isonicotinic acid hydrazide
intervention type: Drug
intervention name: Placebo
description: 3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
arm group label: Placebo Comparator
criteria: 
gender: Female
gender based: Yes
gender description: nulliparous women with primary infertility
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: nahla w Shady, md
role: Study Chair
affiliation: Aswan universirty
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: A Professor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Isoniazid
sharing ipd: No