NCT01725477

Brief Summary

  1. 1.Methylene blue in laparoscopy use for tubal patency assessment
  2. 2.Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and fertility.
  3. 3.tubal washing after Methylene blue administration could be effective in pregnancy rate after operation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2015

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

October 25, 2012

Last Update Submit

April 8, 2017

Conditions

Methylene BlueLaparoscopyTubal Patency

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    up to 12 weeks

Secondary Outcomes (1)

  • complications rate in two group

    Up to 12 weeks

Other Outcomes (1)

  • Abortion rate

    Up to 12 weeks

Study Arms (2)

Dye& normal saline/ 20ml methylene blue +50 ml normal saline

EXPERIMENTAL

first arm:20 ml methylene blue washing with50 ml normal saline

Drug: methylen blue &normal salineDrug: methylene blueDrug: metheylne blue with normal saline

injection of 20ml metheylen blue

ACTIVE COMPARATOR

20 ml methylene blue injected without washing

Drug: methylene blue

Interventions

methylen blue &normal salineDRUG

Washing after dye injection

Also known as: DYE, Methylene BLUE
Dye& normal saline/ 20ml methylene blue +50 ml normal saline
methylene blueDRUG
Dye& normal saline/ 20ml methylene blue +50 ml normal salineinjection of 20ml metheylen blue
metheylne blue with normal salineDRUG
Dye& normal saline/ 20ml methylene blue +50 ml normal saline

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women with unexplained infertility

You may not qualify if:

  • any intervention during operation like ovarian drilling or septum resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahvaz Jundishapur university of medical science

Ahvāz, Iran

Location

Related Publications (1)

  • 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.

    PMID: 9445235RESULT

MeSH Terms

Interventions

Saline SolutionColoring AgentsMethylene Blue

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and UsesPhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2012

First Posted

November 12, 2012

Study Start

September 1, 2012

Primary Completion

February 14, 2014

Study Completion

March 9, 2015

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

IR(1)