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Laparoscopic Tubal Patency Assessment

Plain-language guide to NCT01725477: not phased randomized trial of Methylene blue (non-peptide stack partner), 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01725477
Phase
not phased
Status
completed
Start
2012-09
Completion (planned or actual)
2014-02-14
Participants
30 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Methylene Blue; Laparoscopy; Tubal Patency
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

Methylene blue in laparoscopy use for tubal patency assessment 2.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to women only aged from 20 years up to 38 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Women with unexplained infertility.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: any intervention during operation like ovarian drilling or septum resection.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Each person switched between Methylene blue (non-peptide stack partner) and the comparison at some point, usually with a gap in between.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2012-09 with completion listed for 2014-02-14.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pregnancy rate (time frame: up to 12 weeks).

It also tracked 1 secondary outcome, for example complications rate in two group.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.