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CompletedNCT01725477Updated Apr 11, 2017

Laparoscopic Tubal Patency Assessment

An interventional study of methylen blue &normal saline and methylene blue in Methylene Blue, Laparoscopy and Tubal Patency, sponsored by Pourmatroud, Elham, M.D.. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 20 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Pourmatroud, Elham, M.D. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 38 Years
Sex
Female
01

Study 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.
Read the 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.

02

Conditions studied

  • Methylene Blue
  • Laparoscopy
  • Tubal Patency
03

In context

Lead sponsor

This is the only study on the registry with Pourmatroud, Elham, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • women with unexplained infertility

Exclusion criteria

Exclusion Criteria:

  • any intervention during operation like ovarian drilling or septum resection
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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 · 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

Interventions

  • Drugmethylen blue &normal saline

    Washing after dye injection

    Also known as: DYE, Methylene BLUE

  • Drugmethylene blue
  • Drugmetheylne blue with normal saline
06

What researchers measure

Primary outcomes

  1. Pregnancy rate

    Time frame: up to 12 weeks

Secondary outcomes

  1. complications rate in two group

    Time frame: Up to 12 weeks

Other outcomes

  1. Abortion rate

    Time frame: Up to 12 weeks

07

Study locations

1 site
  • Ahvaz Jundishapur university of medical science
    Ahvaz, Iran, Islamic Republic of
08

References and documents

Publications

  • Galili Y, Ben-Abraham R, Rabau M, Klausner J, Kluger Y. Reduction of surgery-induced peritoneal adhesions by methylene blue. Am J Surg. 1998 Jan;175(1):30-2. doi: 10.1016/s0002-9610(97)00232-8. PubMed 9445235 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01725477
Lead sponsor
Pourmatroud, Elham, M.D.
Responsible party
Sponsor
First posted
Nov 12, 2012
Start date
Sep 2012
Primary completion
Feb 14, 2014
Completion
Mar 9, 2015
Last update
Apr 11, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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