Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06228469
Status:
RECRUITING
Last Update Posted:
2025-03-30
First Post:
2024-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytolytic Vaginosis Multicentre Registry
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
Cytolytic Vaginosis Multicentre Registry
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are:
* What are risk factors of cytolytic vaginosis?
* Are there defining symptoms of cytolytic vaginosis?
* What features on wet mount should be used to diagnosis cytolytic vaginosis?
* Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis?
* Do characteristics of cytolytic vaginosis vary between sites/countries?
* What are risk factors of cytolytic vaginosis?
* Are there defining symptoms of cytolytic vaginosis?
* What features on wet mount should be used to diagnosis cytolytic vaginosis?
* Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis?
* Do characteristics of cytolytic vaginosis vary between sites/countries?
Detailed Description:
Cytolytic vaginosis is a largely unknown, debated, and equivocal vaginal condition. It is unclear whether cytolytic vaginosis is a variant of normal vaginal microbiome or should be considered a vaginal dysbiosis condition, similar to bacterial vaginosis. This multicentre registry will enroll women that have signs/symptoms consistent with cytolytic vaginosis to better characterize it.
Women at participating sites diagnosed with cytolytic vaginosis and that provide consent will be consecutively enrolled in the registry. The registry will capture data on risk factors, symptoms, test results (eg, wet mount) and treatment outcomes.
Women at participating sites diagnosed with cytolytic vaginosis and that provide consent will be consecutively enrolled in the registry. The registry will capture data on risk factors, symptoms, test results (eg, wet mount) and treatment outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: