Darwishscope Versus Flow Test and Bubble Flow Test in Infertility

Sponsor

Woman's Health University Hospital, Egypt (Other)

Overall Status

Recruiting

CT.gov ID

NCT04825041

Collaborator

(none)

155

Enrollment

Location

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tubal Patency	Diagnostic Test: Patency test

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

155 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Darwishscope Versus Flow Test and Bubble Flow Test in Infertility

Actual Study Start Date :

Aug 27, 2021

Actual Primary Completion Date :

Sep 22, 2021

Anticipated Study Completion Date :

Aug 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Infertilite women Subjected to three successive hysteroscopic tests	Diagnostic Test: Patency test Successive flow test, bubble flow test and peristalsis test

Arm

Intervention/Treatment

Infertilite women

Subjected to three successive hysteroscopic tests

Diagnostic Test: Patency test

Successive flow test, bubble flow test and peristalsis test

Outcome Measures

Primary Outcome Measures

FT patency [6 months]
Success of the diagnostic test to assess FT patency.
Specificity [6 months]
Effect of combination of more one test to assess tubal patency.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

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, Woman's Health University Hospital, Egypt

ClinicalTrials.gov Identifier:

NCT04825041

Other Study ID Numbers:

2021

First Posted:

Apr 1, 2021

Last Update Posted:

Sep 29, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Professor Atef Darwish, Professor of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Sep 29, 2021