Laparoscopic Tubal Patency Assessment

Not Applicable

Completed

• Conditions: Methylene Blue; Laparoscopy; Tubal Patency
• Interventions: Drug: methylen blue &normal saline; Drug: methylene blue; Drug: metheylne blue with normal saline

• Registration Number: NCT01725477
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-12
• Primary Completion: 2014-02-14
• Study Completion: 2015-03-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• women with unexplained infertility

Exclusion Criteria

• any intervention during operation like ovarian drilling or septum resection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dye& normal saline/ 20ml methylene blue +50 ml normal saline	methylen blue &normal saline	first arm:20 ml methylene blue washing with50 ml normal saline
Dye& normal saline/ 20ml methylene blue +50 ml normal saline	methylene blue	first arm:20 ml methylene blue washing with50 ml normal saline
Dye& normal saline/ 20ml methylene blue +50 ml normal saline	metheylne blue with normal saline	first arm:20 ml methylene blue washing with50 ml normal saline
injection of 20ml metheylen blue	methylene blue	20 ml methylene blue injected without washing

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
complications rate in two group	Up to 12 weeks

Trial Locations

Locations (1)

Ahvaz Jundishapur university of medical science; 🇮🇷 Ahvaz, Iran, Islamic Republic of