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Completed

NCT Number: NCT03953586

Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix

Tubal patency testing is essential for infertility evaluation. Standard tests are hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble suction test was described in apparently normal tubes. However, the efficacy of bubble suction test in abnormal tubes like hydrosalpnix has not been studied.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Woman's Health University Hospital

Asyut, 71111, Egypt

About this study

Nowadays, hysteroscopy is extensively used for fertility assessment. In a previous study, it is recommended to add hysteroscopy to the routine infertility work-up to achieve a better assessment of infertility cases.

In 2016, hysteroscopy as a predictor test of tubal patency and tubal peristalsis was introduced. It is concluded that hysteroscopic bubble suction test is a good initial screening test for tubal patency nearly comparable to HSG and DL. It should be attempted in every case of OH prior to referral for more invasive HSG or laparoscopic chromopertubation test.

Thereafter, some authors tried the same idea of bubble suction test and were over-enthusiastic with this test and considered it superior to hysterosalpingography (HSG) in detection of tubal patency in infertile women. They wrongly described HSG as a historic tool despite being recommended as a basic infertility test by many organizations. Some authors criticized the results of these studies and underestimated their clinical implication. One of the objections were lack of differentiation between normal tubes and damaged or narrowed but still patent tubes.

Aim of the work:

To test whether bubble suction test and osteal peristalsis are preserved or lost in cases with hydrosalpnix.

Design: A prospective double blinded randomized controlled trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion criteria

  • No HSG

Treatment and study plan

Bubble suction test and tubal peristalsis

Diagnostic Test

Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)

Primary outcomes

  1. percentage of positive tests in both pathologic and healthy tubes

    Time frame: 6 months

    Bubble suction test+ tubal peristalsis

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 16, 2019
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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