Cytolytic Vaginosis Multicentre Registry

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?

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Key information

Conditions

Cytolytic Vaginosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Discharge Vaginal Diseases Vaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universidade Federal Fluminense-UFF, Niterói, Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Characterize cytolytic vaginosis

Time frame: 1 year

Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 29, 2024
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed