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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04825041
Other study ID # 2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 27, 2022

Study information

Verified date January 2024
Source Woman's Health University Hospital, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date September 27, 2022
Est. primary completion date September 22, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Patency test
Successive flow test, bubble flow test and peristalsis test

Locations

Country Name City State
Egypt Woman's Health University Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary FT patency Success of each diagnostic test to assess FT patency. 6 months
See also
  Status Clinical Trial Phase
Completed NCT01725477 - Laparoscopic Tubal Patency Assessment N/A
Active, not recruiting NCT05079685 - HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.
Completed NCT02146248 - HSG and Tubal Patency Study N/A
Terminated NCT01880073 - FemVue and Tubal Patency N/A
Recruiting NCT02505555 - Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency N/A
Completed NCT03953586 - Hysteroscopic Bubble Suction Test and Tubal Peristalsis (Darwish Test) in Hydrosalpnix