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

Completed

• Conditions: Tubal Patency
• Interventions: Diagnostic Test: Bubble suction test and tubal peristalsis

• Registration Number: NCT03953586
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-05-12
• Study First Submitted QC: 2019-05-14
• Study First Posted: 2019-05-16
• Study Start: 2019-12-10
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-20
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion Criteria

• No HSG

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bubble suction test and peristalsis in hydrosalpnix	Bubble suction test and tubal peristalsis	. Group A: Women with unilateral or bilateral blockage of the distal end of the fallopian tubes with tubal distension.
bubble suction test and peristalsis in normal tubes	Bubble suction test and tubal peristalsis	Group B: Women with normal appearance of the fallopian tubes by HSG.

Primary Outcome Measures

Name	Time	Method
percentage of positive tests in both pathologic and healthy tubes	6 months	Bubble suction test+ tubal peristalsis

Trial Locations

Locations (1)

Woman's Health University Hospital; 🇪🇬 Assiut, Egypt