Methylene BlueNCT01725477
Laparoscopic Tubal Patency Assessment
A study testing methylen blue &normal saline, methylene blue and metheylne blue with normal saline in people with Methylene Blue and Laparoscopy, run by Pourmatroud, Elham, M.D. at 1 site in Iran.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Methylene Blue, Laparoscopy, Tubal Patency
- What is being tested?
- methylen blue &normal saline, methylene blue and metheylne blue with normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Sep 2012to 9 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women with unexplained infertility
Who cannot join
- any intervention during operation like ovarian drilling or septum resection
Trial locations and contacts
1 site in 1 country.
About this study
- Methylene blue in laparoscopy use for tubal patency assessment
- Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and fertility.
- 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.
- Conditions
- Methylene Blue, Laparoscopy, Tubal Patency
- Being tested
- methylen blue &normal saline, methylene blue, metheylne blue with normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylen blue &normal salineDrug
Also called DYE, Methylene BLUE
Washing after dye injection
methylene blueDrug
metheylne blue with normal salineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dye& normal saline/ 20ml methylene blue +50 ml normal saline | Experimental | first arm:20 ml methylene blue washing with50 ml normal saline Receives: Drug: methylen blue &normal saline; Drug: methylene blue; Drug: metheylne blue with normal saline |
| injection of 20ml metheylen blue | Active comparator | 20 ml methylene blue injected without washing Receives: Drug: methylene blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: up to 12 weeks
Secondary outcomes (1)
complications rate in two group
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startSep 2012
- Primary completion14 Feb 2014
- Study completion9 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methylene BlueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pourmatroud, Elham, M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725477
- Sponsor's protocol ID
- Methylen blue
- Other IDs
- Methylen blue in laparoscopy
- Status last verified
- Apr 2017
- First submitted
- 25 Oct 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Tubal Patency Assessment
- ClinicalTrials.gov ID
- NCT01725477
- Acronym / sponsor ID
- Methylen blue
- Conditions
- Methylene Blue, Laparoscopy, Tubal Patency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pourmatroud, Elham, M.D.
- Study start
- Sep 2012
- Primary completion
- 14 Feb 2014 (actual)
- Study completion
- 9 Mar 2015 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Methylene blue in laparoscopy use for tubal patency assessment
- Methylene blue could have negative effect on sperm motility, oocyte granulosa cell and fertility.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dye& normal saline/ 20ml methylene blue +50 ml normal saline | Experimental | Drug: methylen blue &normal saline, Drug: methylene blue, Drug: metheylne blue with normal salinefirst arm:20 ml methylene blue washing with50 ml normal saline |
| injection of 20ml metheylen blue | Active comparator | Drug: methylene blue20 ml methylene blue injected without washing |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with unexplained infertility
Key exclusion criteria (1 listed)
- any intervention during operation like ovarian drilling or septum resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylen blue &normal salineAlso: DYE, Methylene BLUEWashing after dye injection | Drug | Dye& normal saline/ 20ml methylene blue +50 ml normal saline |
| methylene blue | Drug | Dye& normal saline/ 20ml methylene blue +50 ml normal saline, injection of 20ml metheylen blue |
| metheylne blue with normal saline | Drug | Dye& normal saline/ 20ml methylene blue +50 ml normal saline |
Primary outcome
Pregnancy rate
Time frame: up to 12 weeks
1 secondary outcome
complications rate in two group
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Results publication: PubMed 9445235Galili 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylen blue &normal saline, methylene blue and metheylne blue with normal saline in people with Methylene Blue and Laparoscopy, run by Pourmatroud, Elham, M.D. at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01725477, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.