Laparoscopic Tubal Patency Assessment

NCT ID: NCT01725477

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-03-09

Brief Summary

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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

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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.

Conditions

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Methylene Blue Laparoscopy Tubal Patency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

methylen blue &normal saline

Intervention Type DRUG

Washing after dye injection

methylene blue

Intervention Type DRUG

metheylne blue with normal saline

Intervention Type DRUG

injection of 20ml metheylen blue

20 ml methylene blue injected without washing

Group Type ACTIVE_COMPARATOR

methylene blue

Intervention Type DRUG

Interventions

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methylen blue &normal saline

Washing after dye injection

Intervention Type DRUG

methylene blue

Intervention Type DRUG

metheylne blue with normal saline

Intervention Type DRUG

Other Intervention Names

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DYE Methylene BLUE

Eligibility Criteria

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Inclusion Criteria

* women with unexplained infertility

Exclusion Criteria

* any intervention during operation like ovarian drilling or septum resection
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pourmatroud, Elham, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ahvaz Jundishapur university of medical science

Ahvāz, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 9445235 (View on PubMed)

Other Identifiers

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Methylen blue in laparoscopy

Identifier Type: REGISTRY

Identifier Source: secondary_id

Methylen blue

Identifier Type: -

Identifier Source: org_study_id

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