Efficacy of Hysteroscopic Bubble Test, Flow Test and Peri... | NCT04825041

Studies
Efficacy of Hysteroscopic Bubble Test, Flow Test and Peristalsis Test.

NCT04825041

Sponsor

Woman's Health University Hospital, Egypt

Status

Completed

Last Update Posted

Jan 23, 2024Actual

Enrollment

155Actual

Phase

Not provided

Conditions

Tubal Patency

Interventions

Patency test

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Actual

Primary Completion Date

Sep 22, 2022Actual

Completion Date

Sep 27, 2022Actual

First Submitted Date

Mar 27, 2021

First Submission Date that Met QC Criteria

Mar 27, 2021

First Posted Date

Apr 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2024

Last Update Posted Date

Jan 23, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Atef Darwish, Professor of Obstetrics and Gynecology, Woman's Health University Hospital, EgyptPrincipal Investigator

Lead Sponsor

Woman's Health University Hospital, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish Hysteroscopic Triad" allows excellent way to assess FT patency. This study compares three ways of assessing FT patency separably or in combination: flow test, bubble flow test and peristalsis test. Combined bubble flow test and peristalsis test is recently published and coined (Darwishscope)1.

Detailed Description

This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA. During hysteroscopy, on each side, three patency test are done successively: flow test, bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is concomitant laparoscopy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

155Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infertilite women		Subjected to three successive hysteroscopic tests	Diagnostic Test: Patency test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patency test	Diagnostic Test	Successive flow test, bubble flow test and peristalsis test	Infertilite women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FT patency	Success of each diagnostic test to assess FT patency.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infertile women
Probably patent FT as proved by a previous hysterosalpingography or laparoscopy.
Office setting.
Postmenstrual
Non use of hormones or hormonal contraceptives.

Exclusion Criteria:

Premenstrual period. Pathologic FT.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Infertility women

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Woman's Health University Hospital		Asyut		71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005186	Fallopian Tube Patency Tests

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D012099	Reproductive Techniques

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Browse Branches

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