NCT04825041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

March 27, 2021

Last Update Submit

January 20, 2024

Conditions

Tubal Patency

Keywords

hysteroscopybubble flow testFlow testPeristalsisDarwishscope

Outcome Measures

Primary Outcomes (1)

  • FT patency

    Success of each diagnostic test to assess FT patency.

    6 months

Study Arms (1)

Infertilite women

Subjected to three successive hysteroscopic tests

Diagnostic Test: Patency test

Interventions

Patency testDIAGNOSTIC_TEST

Successive flow test, bubble flow test and peristalsis test

Infertilite women

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Infertility women

You may qualify if:

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

You may not qualify if:

  • Premenstrual period. Pathologic FT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Fallopian Tube Patency Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 27, 2021

First Posted

April 1, 2021

Study Start

September 1, 2021

Primary Completion

September 22, 2022

Study Completion

September 27, 2022

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)