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

NCT ID: NCT03953586

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-08-20

Brief Summary

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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

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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.

Conditions

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Tubal Patency

Keywords

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laparoscopy hysteroscopy, tubal patency, bubble test, peristalsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Bubble suction test and tubal peristalsis

Intervention Type DIAGNOSTIC_TEST

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.

Bubble suction test and tubal peristalsis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Bubble suction test and tubal peristalsis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion Criteria

* No HSG
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Professor Atef Darwish

Professor of Obstetrics and Gynecology, Assiut University, Assiut, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Woman's Health University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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WomansHealthUHEgypt

Identifier Type: -

Identifier Source: org_study_id