NCT03953586

Brief Summary

Tubal patency testing is essential for infertility evaluation. Standard tests are hysterosalpingography and laparoscopic perchromation test. In 2016, a hysteroscopic bubble suction test was described in apparently normal tubes. However, the efficacy of bubble suction test in abnormal tubes like hydrosalpnix has not been studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

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

May 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

May 12, 2019

Last Update Submit

December 9, 2020

Conditions

Tubal Patency

Keywords

laparoscopyhysteroscopy,tubal patency,bubble test,peristalsis

Outcome Measures

Primary Outcomes (1)

  • percentage of positive tests in both pathologic and healthy tubes

    Bubble suction test+ tubal peristalsis

    6 months

Study Arms (2)

bubble suction test and peristalsis in hydrosalpnix

. Group A: Women with unilateral or bilateral blockage of the distal end of the fallopian tubes with tubal distension.

Diagnostic Test: Bubble suction test and tubal peristalsis

bubble suction test and peristalsis in normal tubes

Group B: Women with normal appearance of the fallopian tubes by HSG.

Diagnostic Test: Bubble suction test and tubal peristalsis

Interventions

Bubble suction test and tubal peristalsisDIAGNOSTIC_TEST

Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)

bubble suction test and peristalsis in hydrosalpnixbubble suction test and peristalsis in normal tubes

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Infertile women with a history of HSG

You may qualify if:

  • Infertility patients scheduled for combined laparoscopy and hysteroscopy

You may not qualify if:

  • No HSG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology, Assiut University, Assiut, Egypt

Study Record Dates

First Submitted

May 12, 2019

First Posted

May 16, 2019

Study Start

December 10, 2019

Primary Completion

August 19, 2020

Study Completion

August 20, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

Locations

EG(1)