ClinicalTrials.gg
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
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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.

02

Conditions studied

  • Tubal Patency

Keywords

  • hysteroscopy
  • bubble flow test
  • Flow test
  • Peristalsis
  • Darwishscope
03

In context

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Premenstrual period. Pathologic FT.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

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

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What researchers measure

Primary outcomes

  1. FT patency

    Success of each diagnostic test to assess FT patency.

    Time frame: 6 months

07

Study locations

1 site
  • Woman's Health University Hospital
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Sep 2022, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2021
First posted
Apr 1, 2021
StartActual
Sep 1, 2021
Primary completionActual
Sep 22, 2022
CompletionActual
Sep 27, 2022
Last update
Jan 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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 ↗

Not currently enrolling

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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Discussion

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