Laparoscopic Tubal Patency Assessment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pourmatroud, Elham, M.D.
ClinicalTrials.gov Identifier:
NCT01725477
First received: October 25, 2012
Last updated: November 9, 2012
Last verified: November 2012
  Purpose
  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 Intervention
Methylene Blue
Laparoscopy
Tubal Patency
Drug: methylen blue &normal saline
Drug: methylene blue
Drug: metheylne blue with normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Pourmatroud, Elham, M.D.:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complications rate in two group [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Abortion rate [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01725477

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

Publications:
Responsible Party: Pourmatroud, Elham, M.D.
ClinicalTrials.gov Identifier: NCT01725477     History of Changes
Other Study ID Numbers: Methylen blue, Methylen blue in laparoscopy, Methylen blue in laparoscopy
Study First Received: October 25, 2012
Last Updated: November 9, 2012
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on July 23, 2014