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Laparoscopic Tubal Patency Assessment

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ClinicalTrials.gov Identifier: NCT01725477
Recruitment Status : Completed
First Posted : November 12, 2012
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Pourmatroud, Elham, M.D.

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
Methylene Blue Laparoscopy Tubal Patency Drug: methylen blue &normal saline Drug: methylene blue Drug: metheylne blue with normal saline Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2012
Actual Primary Completion Date : February 14, 2014
Actual Study Completion Date : March 9, 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. complications rate in two group [ Time Frame: Up to 12 weeks ]

Other Outcome Measures:
  1. Abortion rate [ Time Frame: Up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with unexplained infertility

Exclusion Criteria:

  • any intervention during operation like ovarian drilling or septum resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725477


Locations
Iran, Islamic Republic of
Ahvaz Jundishapur university of medical science
Ahvaz, Iran, Islamic Republic of
Sponsors and Collaborators
Pourmatroud, Elham, M.D.

Publications of Results:
Responsible Party: Pourmatroud, Elham, M.D.
ClinicalTrials.gov Identifier: NCT01725477     History of Changes
Other Study ID Numbers: Methylen blue
Methylen blue in laparoscopy ( Registry Identifier: PourmatroudE )
First Posted: November 12, 2012    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action