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Cytolytic Vaginosis Multicentre Registry

Cytolytic Vaginosis Multicentre Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06228469
Enrollment
32
Registered
2024-01-29
Start date
2024-03-01
Completion date
2025-12-31
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytolytic Vaginosis

Keywords

Vaginitis, Lactobacillus, Wet mount, Vaginal microbiome, Fragmented epithelial cells, Vaginal discharge

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.

Interventions

None listed

Sponsors

University of Alberta
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Characterize cytolytic vaginosis1 yearDescribe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis

Countries

Brazil, Canada, Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 15, 2026