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

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

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.

Study Overview

• Status: Completed
• Conditions: Tubal Patency
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Woman's Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Infertility women

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Woman's Health University Hospital, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 27, 2022

Study Registration Dates

• First Submitted: March 27, 2021
• First Submitted That Met QC Criteria: March 27, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hysteroscopy; Peristalsis; bubble flow test; Flow test; Darwishscope
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No