<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/NCT04500470</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/351/3/19</org_study_id>
    <nct_id>NCT04500470</nct_id>
  </id_info>
  <brief_title>Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide Prior to Hysterosalpingography</brief_title>
  <official_title>Ketoprofen With or Without Vaginal Isonicotinic Acid Hydrazide (INH) Prior to Hysterosalpingography 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>
      The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal&#xD;
      isonicotinic acid hydrazide on the pain scores during HSG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to&#xD;
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions&#xD;
      including measuring uterine depth, inserting the cannula; and injection of the dye&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 30, 2021</primary_completion_date>
  <phase>N/A</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 placebo randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind placebo randomized controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of pain</measure>
    <time_frame>15 minutes</time_frame>
    <description>pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable</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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoprofen + INH</intervention_name>
    <description>patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketoprofen + placebo</intervention_name>
    <description>patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient came for Hysterosalpingography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any patient has contraindication to HSG&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female candidate for 30 minutes after the procedure</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 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>January 2022</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>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</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>Ketoprofen</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/NCT04500470
org study id: aswu/351/3/19
nct id: NCT04500470
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of our study is to determine the efficacy of Ketoprofen with or without vaginal
      isonicotinic acid hydrazide on the pain scores during HSG.
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to
      grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions
      including measuring uterine depth, inserting the cannula; and injection of the dye
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind placebo randomized controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind placebo randomized controlled trial
measure: Intensity of pain
time frame: 15 minutes
description: pain during the procedure assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
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
arm group label: Group A
arm group type: Experimental
description: patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
arm group label: Group B
arm group type: Placebo Comparator
description: patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table vaginal placebo by the patient 12 hours before the procedure
intervention type: Drug
intervention name: Ketoprofen + INH
description: patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
arm group label: Group A
intervention type: Drug
intervention name: Ketoprofen + placebo
description: patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure
arm group label: Group B
criteria: 
gender: Female
gender based: Yes
gender description: female candidate for 30 minutes after the procedure
minimum age: 18 Years
maximum age: 40 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: Ketoprofen
sharing ipd: No