Laparoscopic Tubal Patency Assessment

April 8, 2017 updated by: Pourmatroud, Elham, M.D.
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with unexplained infertility

Exclusion Criteria:

  • any intervention during operation like ovarian drilling or septum resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: up to 12 weeks
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
complications rate in two group
Time Frame: Up to 12 weeks
Up to 12 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Abortion rate
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pourmatroud, Elham, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 14, 2014

Study Completion (Actual)

March 9, 2015

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 12, 2012

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Methylen blue
  • Methylen blue in laparoscopy (Registry Identifier: PourmatroudE)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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