<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/NCT01725477</url>
  </required_header>
  <id_info>
    <org_study_id>Methylen blue</org_study_id>
    <secondary_id>Methylen blue in laparoscopy</secondary_id>
    <nct_id>NCT01725477</nct_id>
  </id_info>
  <brief_title>Laparoscopic Tubal Patency Assessment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pourmatroud, Elham, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pourmatroud, Elham, M.D.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Methylene blue in laparoscopy use for tubal patency assessment&#xD;
&#xD;
        2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and&#xD;
           fertility.&#xD;
&#xD;
        3. tubal washing after Methylene blue administration could be effective in pregnancy rate&#xD;
           after operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      women with unexplained infertility and without any problem during laparoscopy and&#xD;
      hysteroscopy entered in the study.After randomization in one group after dye test,washing&#xD;
      with normal saline was done until all of visible Methylene blue removed.In second group&#xD;
      washing with normal saline did not done. pregnancy rate until three months after operation&#xD;
      was followed without any intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 9, 2015</completion_date>
  <primary_completion_date type="Actual">February 14, 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>up to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>complications rate in two group</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Abortion rate</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Methylene Blue</condition>
  <condition>Laparoscopy</condition>
  <condition>Tubal Patency</condition>
  <arm_group>
    <arm_group_label>Dye&amp; normal saline/ 20ml methylene blue +50 ml normal saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>first arm:20 ml methylene blue washing with50 ml normal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>injection of 20ml metheylen blue</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml methylene blue injected without washing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methylen blue &amp;normal saline</intervention_name>
    <description>Washing after dye injection</description>
    <arm_group_label>Dye&amp; normal saline/ 20ml methylene blue +50 ml normal saline</arm_group_label>
    <other_name>DYE</other_name>
    <other_name>Methylene BLUE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methylene blue</intervention_name>
    <arm_group_label>Dye&amp; normal saline/ 20ml methylene blue +50 ml normal saline</arm_group_label>
    <arm_group_label>injection of 20ml metheylen blue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metheylne blue with normal saline</intervention_name>
    <arm_group_label>Dye&amp; normal saline/ 20ml methylene blue +50 ml normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with unexplained infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any intervention during operation like ovarian drilling or septum resection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ahvaz Jundishapur university of medical science</name>
      <address>
        <city>Ahvaz</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Galili Y, Ben-Abraham R, Rabau M, Klausner J, Kluger Y. Reduction of surgery-induced peritoneal adhesions by methylene blue. Am J Surg. 1998 Jan;175(1):30-2. doi: 10.1016/s0002-9610(97)00232-8.</citation>
    <PMID>9445235</PMID>
  </results_reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>April 8, 2017</last_update_submitted>
  <last_update_submitted_qc>April 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylene Blue</mesh_term>
  </intervention_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/NCT01725477
org study id: Methylen blue
secondary id: Methylen blue in laparoscopy
nct id: NCT01725477
lead sponsor: 
has dmc: Yes
1. Methylene blue in laparoscopy use for tubal patency assessment

        2. Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and
           fertility.

        3. tubal washing after Methylene blue administration could be effective in pregnancy rate
           after operation.
women with unexplained infertility and without any problem during laparoscopy and
      hysteroscopy entered in the study.After randomization in one group after dye test,washing
      with normal saline was done until all of visible Methylene blue removed.In second group
      washing with normal saline did not done. pregnancy rate until three months after operation
      was followed without any intervention.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pregnancy rate
time frame: up to 12 weeks
measure: complications rate in two group
time frame: Up to 12 weeks
measure: Abortion rate
time frame: Up to 12 weeks
arm group label: Dye& normal saline/ 20ml methylene blue +50 ml normal saline
arm group type: Experimental
description: first arm:20 ml methylene blue washing with50 ml normal saline
arm group label: injection of 20ml metheylen blue
arm group type: Active Comparator
description: 20 ml methylene blue injected without washing
intervention type: Drug
intervention name: methylen blue &normal saline
description: Washing after dye injection
arm group label: Dye& normal saline/ 20ml methylene blue +50 ml normal saline
other name: DYE
other name: Methylene BLUE
intervention type: Drug
intervention name: methylene blue
arm group label: Dye& normal saline/ 20ml methylene blue +50 ml normal saline
arm group label: injection of 20ml metheylen blue
intervention type: Drug
intervention name: metheylne blue with normal saline
arm group label: Dye& normal saline/ 20ml methylene blue +50 ml normal saline
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
citation: Galili Y, Ben-Abraham R, Rabau M, Klausner J, Kluger Y. Reduction of surgery-induced peritoneal adhesions by methylene blue. Am J Surg. 1998 Jan;175(1):30-2. doi: 10.1016/s0002-9610(97)00232-8.
PMID: 9445235
responsible party type: Sponsor
mesh term: Methylene Blue