Clincosm LogoSign in Get a demo

Laparoscopic Tubal Patency Assessment

Sponsor
Pourmatroud, Elham, M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT01725477
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
30.2
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  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.

Condition or Disease Intervention/Treatment Phase
  • Drug: methylen blue &normal saline
  • Drug: methylene blue
  • Drug: metheylne blue with normal saline
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Feb 14, 2014
Actual Study Completion Date :
Mar 9, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dye& normal saline/ 20ml methylene blue +50 ml normal saline

first arm:20 ml methylene blue washing with50 ml normal saline

Drug: methylen blue &normal saline
Washing after dye injection
Other Names:
  • DYE
  • Methylene BLUE

    • Drug: methylene blue

    Drug: metheylne blue with normal saline
    Active Comparator: injection of 20ml metheylen blue

    20 ml methylene blue injected without washing

    Drug: methylene blue

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate [up to 12 weeks]

    Secondary Outcome Measures

    1. complications rate in two group [Up to 12 weeks]

    Other Outcome Measures

    1. Abortion rate [Up to 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • women with unexplained infertility
    Exclusion Criteria:
    • any intervention during operation like ovarian drilling or septum resection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahvaz Jundishapur university of medical science Ahvaz Iran, Islamic Republic of

    Sponsors and Collaborators

    • Pourmatroud, Elham, M.D.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pourmatroud, Elham, M.D.
    ClinicalTrials.gov Identifier:
    NCT01725477
    Other Study ID Numbers:
    • Methylen blue
    • Methylen blue in laparoscopy
    First Posted:
    Nov 12, 2012
    Last Update Posted:
    Apr 11, 2017
    Last Verified:
    Apr 1, 2017
    Additional relevant MeSH terms:
    Methylene Blue

    Study Results

    No Results Posted as of Apr 11, 2017