CompletedNCT04825041Updated Jan 23, 2024

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

An observational study in Tubal Patency, sponsored by Woman's Health University Hospital, Egypt. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Woman's Health University Hospital, Egypt · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 155
Ages: 18 Years to 40 Years
Sex: Female

Study 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.

Read the 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.

Conditions studied

Tubal Patency

Keywords

hysteroscopy
bubble flow test
Flow test
Peristalsis
Darwishscope

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Infertility women

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

Exclusion Criteria:

Premenstrual period. Pathologic FT.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 155 participants (actual)
Patient registry: No

Groups and cohorts

Infertilite women
Subjected to three successive hysteroscopic tests
Diagnostic Test: Patency test

Interventions

Diagnostic testPatency test
Successive flow test, bubble flow test and peristalsis test

What researchers measure

Primary outcomes

FT patency
Success of each diagnostic test to assess FT patency.
Time frame: 6 months

Study locations

1 site

Woman's Health University Hospital
Assiut, 71111, Egypt

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT04825041
Lead sponsor: Woman's Health University Hospital, Egypt
Responsible party: Professor Atef Darwish (Professor of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt) — Principal investigator
First posted: Apr 1, 2021
Start date: Sep 1, 2021
Primary completion: Sep 22, 2022
Completion: Sep 27, 2022
Last update: Jan 23, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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