<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/NCT04500509</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/352/3/19</org_study_id>
    <nct_id>NCT04500509</nct_id>
  </id_info>
  <brief_title>Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography</brief_title>
  <official_title>Diclofenac Potassium With or Without Vaginal Dinoprostone 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 oral diclofenac potassium with or&#xD;
      without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients&#xD;
      on the pain scores during HSG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and&#xD;
      considered to be the traditional and the gold standard in the assessment of the patency of&#xD;
      the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study&#xD;
      reported the patients complained of moderate to severe pain during the procedure. It is&#xD;
      reported that some patients undergoing hysterosalpingography was more stressful and anxiety&#xD;
      and effect on pain scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">October 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 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 controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind placebo controlled trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean pain score during hysterosalpigography by visual analog scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>pain during hysterosalpigography 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 diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to 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 diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>diclofenac potassium + dinoprostone</intervention_name>
    <description>patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>diclofenac potassium + placebo</intervention_name>
    <description>patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient</description>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary infertility female came for HSG&#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>primary infertility female</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>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>Diclofenac</mesh_term>
    <mesh_term>Dinoprostone</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/NCT04500509
org study id: aswu/352/3/19
nct id: NCT04500509
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 oral diclofenac potassium with or
      without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients
      on the pain scores during HSG.
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and
      considered to be the traditional and the gold standard in the assessment of the patency of
      the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study
      reported the patients complained of moderate to severe pain during the procedure. It is
      reported that some patients undergoing hysterosalpingography was more stressful and anxiety
      and effect on pain scores.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind placebo controlled trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blind placebo controlled trial
measure: Mean pain score during hysterosalpigography by visual analog scale
time frame: 15 minutes
description: pain during hysterosalpigography 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 diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure
arm group label: Group B
arm group type: Placebo Comparator
description: patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure
intervention type: Drug
intervention name: diclofenac potassium + dinoprostone
description: patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient
arm group label: Group A
intervention type: Drug
intervention name: diclofenac potassium + placebo
description: patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient
arm group label: Group B
criteria: 
gender: Female
gender based: Yes
gender description: primary infertility female
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: Diclofenac
mesh term: Dinoprostone
sharing ipd: No