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Laparoscopic Tubal Patency Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pourmatroud, Elham, M.D.
ClinicalTrials.gov Identifier:
NCT01725477
First received: October 25, 2012
Last updated: April 8, 2017
Last verified: April 2017
  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
Intervention Model: Crossover Assignment
Masking: Participant, 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 ]

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

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

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: March 9, 2015
Primary Completion Date: February 14, 2014 (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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 ( Registry Identifier: PourmatroudE )
Study First Received: October 25, 2012
Last Updated: April 8, 2017

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

ClinicalTrials.gov processed this record on July 21, 2017