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

• Sponsor: Woman's Health University Hospital, Egypt (Other)
• Overall Status: Completed
• CT.gov ID: NCT03953586
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 10.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tubal Patency	Diagnostic Test: Bubble suction test and tubal peristalsis

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 Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix
• Actual Study Start Date: Dec 10, 2019
• Actual Primary Completion Date: Aug 19, 2020
• Actual Study Completion Date: Aug 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
bubble suction test and peristalsis in hydrosalpnix . Group A: Women with unilateral or bilateral blockage of the distal end of the fallopian tubes with tubal distension.	Diagnostic Test: Bubble suction test and tubal peristalsis; Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)
bubble suction test and peristalsis in normal tubes Group B: Women with normal appearance of the fallopian tubes by HSG.	Diagnostic Test: Bubble suction test and tubal peristalsis; Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)

Outcome Measures

Primary Outcome Measures

1. percentage of positive tests in both pathologic and healthy tubes [6 months]

   Bubble suction test+ tubal peristalsis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion Criteria:

• No HSG

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woman's Health University Hospital	Assiut		Egypt	71111

Sponsors and Collaborators

• Woman's Health University Hospital, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Atef Darwish, Professor of Obstetrics and Gynecology, Assiut University, Assiut, Egypt, Woman's Health University Hospital, Egypt
• ClinicalTrials.gov Identifier: NCT03953586
• Other Study ID Numbers: WomansHealthUHEgypt
• First Posted: May 16, 2019
• Last Update Posted: Dec 10, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Professor Atef Darwish, Professor of Obstetrics and Gynecology, Assiut University, Assiut, Egypt, Woman's Health University Hospital, Egypt: laparoscopy; hysteroscopy,; tubal patency,; bubble test,; peristalsis

Study Results

No Results Posted as of Dec 10, 2020