<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/NCT03826823</url>
  </required_header>
  <id_info>
    <org_study_id>1-Mansour</org_study_id>
    <nct_id>NCT03826823</nct_id>
  </id_info>
  <brief_title>Thin Catheter for Hysterosalpigography</brief_title>
  <official_title>Hysterosalpigography Using a Thin Catheter and Closing the Cervix With the Vaginal Speculum to Reduce the Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an&#xD;
      attractive alternative . we conducted a randomised controlled trial to compare the standard&#xD;
      metal cannula to the thin catheter originally manufactured for intrauterine insemination.&#xD;
      Pain assessment was done using visual analogue scale&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HSG is widely practiced in our country, however, for cost effective reasons, the standard&#xD;
      metal cannula is the only method used at our hospital. It is painful procedure because it&#xD;
      requires grasping the cervix with a tenaculum and inducing some cervical dilatation during&#xD;
      introduction of the cannula. The aim of this pilot study was to modify the technique of HSG&#xD;
      using a thinner than normal catheter, and without grasping the cervix with a tenaculum.&#xD;
      Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the&#xD;
      cervix using the vaginal speculum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">July 2010</completion_date>
  <primary_completion_date type="Actual">February 2010</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the level of pain using a visual analogue scale (VAS)</measure>
    <time_frame>8 month</time_frame>
    <description>pain score will be assessed during introduction of catheter and during the injection of dye</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visualising uterus and tubes</measure>
    <time_frame>8 month</time_frame>
    <description>the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>infertile women</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>infertile women undergoing hysterosalpingography for evaluating fallopian tubes</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HSG cannula</intervention_name>
    <description>a thin catheter originally designed for IUI was introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum was loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye was injected slowly and the procedure was watched on the screen and x-ray films were taken.</description>
    <arm_group_label>infertile women</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infertile women seeking evaluation of fallopian tubes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any woman with allergy to the iodine dye or condition contraindicating pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2008</verification_date>
  <study_first_submitted>July 11, 2011</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Egyptian IVF-ET Center</investigator_affiliation>
    <investigator_full_name>Ragaa Mansour</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>hysterosalpingography, catheter, pain, visual analogue scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT03826823
org study id: 1-Mansour
nct id: NCT03826823
lead sponsor: 
has dmc: No
Hysterosalpingography is usually painful and the use of thin catheters of IUI could be an
      attractive alternative . we conducted a randomised controlled trial to compare the standard
      metal cannula to the thin catheter originally manufactured for intrauterine insemination.
      Pain assessment was done using visual analogue scale
HSG is widely practiced in our country, however, for cost effective reasons, the standard
      metal cannula is the only method used at our hospital. It is painful procedure because it
      requires grasping the cervix with a tenaculum and inducing some cervical dilatation during
      introduction of the cannula. The aim of this pilot study was to modify the technique of HSG
      using a thinner than normal catheter, and without grasping the cervix with a tenaculum.
      Leakage of the dye through the cervix was prevented by pressing on the portiovaginalis of the
      cervix using the vaginal speculum.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: the level of pain using a visual analogue scale (VAS)
time frame: 8 month
description: pain score will be assessed during introduction of catheter and during the injection of dye
measure: visualising uterus and tubes
time frame: 8 month
description: the efficiency of the new technique in filling the uterine cavity with the dye and studying fallopian tubes.
arm group label: infertile women
arm group type: Experimental
description: infertile women undergoing hysterosalpingography for evaluating fallopian tubes
intervention type: Device
intervention name: HSG cannula
description: a thin catheter originally designed for IUI was introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum was loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye was injected slowly and the procedure was watched on the screen and x-ray films were taken.
arm group label: infertile women
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The Egyptian IVF-ET Center
investigator full name: Ragaa Mansour
investigator title: Director
mesh term: Infertility