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Hysteroscopic Bubble Suction Test and Tubal Peristalsis in Hydrosalpnix

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ClinicalTrials.gov Identifier: NCT03953586
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Atef Darwish, 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.

Condition or disease Intervention/treatment
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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hysteroscopic Bubble Suction Test and Tubal Peristalsis in Hydrosalpnix
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort 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)




Primary Outcome Measures :
  1. percentage of positive tests in both pathologic and healthy tubes [ Time Frame: 6 months ]
    Bubble suction test+ tubal peristalsis



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infertile women with a history of HSG
Criteria

Inclusion Criteria:

  • Infertility patients scheduled for combined laparoscopy and hysteroscopy

Exclusion Criteria:

  • No HSG

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953586


Contacts
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Contact: Atef Darwish 0201001572723 atef_darwish@yahoo.com

Sponsors and Collaborators
Woman's Health University Hospital, Egypt

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Responsible Party: Professor Atef Darwish, Professor of Obstetrics and Gynecology, Assiut University, Assiut, Egypt, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT03953586     History of Changes
Other Study ID Numbers: WomansHealthUHEgypt
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professor Atef Darwish, Woman's Health University Hospital, Egypt:
laparoscopy
hysteroscopy,
tubal patency,
bubble test,
peristalsis