Cytolytic Vaginosis Multicentre Registry

Recruiting

• Conditions: Cytolytic Vaginosis

• Registration Number: NCT06228469
• Lead Sponsor: University of Alberta

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?

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.

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-18
• Study First Posted: 2024-01-29
• Study Start: 2024-03-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Vaginitis symptoms
• Predominately lactobacilli or/and elongated lactobacilli on wet mount
• Cytolysis on wet mount

Exclusion Criteria

• Unable to consent or decline consent
• Pregnant
• Positive for yeast (culture or PCR)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize cytolytic vaginosis	1 year	Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis

Trial Locations

Locations (3)

Outpatient clinics; 🇨🇦 Multiple Locations, Alberta, Canada

Universidade Federal Fluminense-UFF; 🇧🇷 Niterói, Rio De Janeiro, Brazil

Centro Hospitalar de São João; 🇵🇹 Porto, Portugal