<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/NCT02977234</url>
  </required_header>
  <id_info>
    <org_study_id>ASU123</org_study_id>
    <nct_id>NCT02977234</nct_id>
  </id_info>
  <brief_title>Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx</brief_title>
  <official_title>Hysteroscopic Tubal Occlusion With the Use of Iso Amyl-2-cyanoacrylate in Patients With Hydrosalpinx</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of hysteroscopic tubal application&#xD;
      of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx,&#xD;
      which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted according to the guidelines on human experimentation of the 1975&#xD;
      Declaration of Helsinki. For all patients after taking signed informed consent ,&#xD;
      transcervical hysteroscopic cannulation of the proximal one centimeter of fallopian tubes&#xD;
      with hydrosalpinx, will be done using a 4 Fr, 42cm long, polyethylene ureteric catheter,&#xD;
      where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected.&#xD;
&#xD;
      All the surgical procedures will be performed without anesthesia, only premedication with an&#xD;
      NSAID (e.g. NaproxenR) is given orally one hour before the procedure.&#xD;
&#xD;
      Each patient will be under close observation for the first 24 hours postprocedure for any&#xD;
      signs of inflammation as abdominal pain, tenderness or fever and for the vital data.&#xD;
&#xD;
      Hysterosalpingography will be done for all patients 0ne and 3 months postinjection to confirm&#xD;
      tubal occlusion prior to IVF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Fallopian tubal occlusion in patients with hydrosalpinx.</measure>
    <time_frame>from one to three months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hydrosalpinx</condition>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Iso-Amyl 2-Cyano Acrylate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isoamyl 2-Cyanoacrylate</intervention_name>
    <arm_group_label>Iso-Amyl 2-Cyano Acrylate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Infertile women due to tubal factor with hydrosalpinx (unilateral or bilateral) prepared&#xD;
        for IVF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute Pelvic inflammatory disease.&#xD;
&#xD;
          2. Intra uterine pathology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed I Amer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University maternity hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed I Amer, MD</last_name>
    <phone>oo2o1oo1519370</phone>
    <email>mohamed_amer810@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>AIn Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11357</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Amer, MD</last_name>
      <phone>00201001519370</phone>
      <email>mohamed_amer810@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 25, 2017</last_update_submitted>
  <last_update_submitted_qc>December 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed I Amer</investigator_full_name>
    <investigator_title>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>
  <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/NCT02977234
org study id: ASU123
nct id: NCT02977234
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the effectiveness of hysteroscopic tubal application
      of Iso Amyl-2-cyanoacrylate in occluding uterine tubes of infertile women with hydrosalpinx,
      which would make it an easy approach for occluding tubes with hydrosalpinx prior to IVF.
The study will be conducted according to the guidelines on human experimentation of the 1975
      Declaration of Helsinki. For all patients after taking signed informed consent ,
      transcervical hysteroscopic cannulation of the proximal one centimeter of fallopian tubes
      with hydrosalpinx, will be done using a 4 Fr, 42cm long, polyethylene ureteric catheter,
      where 0.5 ml of Iso Amyl-2-cyanoacrylate (AMCRYLATE®) will be injected.

      All the surgical procedures will be performed without anesthesia, only premedication with an
      NSAID (e.g. NaproxenR) is given orally one hour before the procedure.

      Each patient will be under close observation for the first 24 hours postprocedure for any
      signs of inflammation as abdominal pain, tenderness or fever and for the vital data.

      Hysterosalpingography will be done for all patients 0ne and 3 months postinjection to confirm
      tubal occlusion prior to IVF.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Fallopian tubal occlusion in patients with hydrosalpinx.
time frame: from one to three months
arm group label: Iso-Amyl 2-Cyano Acrylate
arm group type: Experimental
description: Hysteroscopic Tubal Occlusion Using Iso-Amyl 2-Cyano Acrylate (Amcrylate) in Patients With Hydrosalpinx
intervention type: Drug
intervention name: Isoamyl 2-Cyanoacrylate
arm group label: Iso-Amyl 2-Cyano Acrylate
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed I Amer, MD
role: Principal Investigator
affiliation: Ain Shams University maternity hospital
last name: Mohamed I Amer, MD
phone: oo2o1oo1519370
email: mohamed_amer810@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed I Amer
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: Undecided