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

Tubal Patency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953586
• Other study ID #: WomansHealthUHEgypt
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: August 20, 2020

Study information

• Verified date: December 2020
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 20, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion Criteria:

• No HSG

Related Conditions & MeSH terms

• Tubal Patency

Intervention

Diagnostic Test:
• Bubble suction test and tubal peristalsis
Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)

Locations

Country	Name	City	State
Egypt	Woman's Health University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of positive tests in both pathologic and healthy tubes	Bubble suction test+ tubal peristalsis	6 months