Cytolytic Vaginosis Multicentre Registry

NCT ID: NCT06228469

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Cytolytic Vaginosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women diagnosed with cytolytic vaginosis

Women presenting to an outpatient clinic with vaginitis symptoms and diagnosed with cytolytic vaginosis.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidade Federal Fluminense-UFF

Niterói, Rio de Janeiro, Brazil

Site Status NOT_YET_RECRUITING

Outpatient clinics

Multiple Locations, Alberta, Canada

Site Status RECRUITING

Centro Hospitalar de São João

Porto, , Portugal

Site Status RECRUITING

Countries

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Brazil Canada Portugal

Central Contacts

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Roni Kraut, MD

Role: CONTACT

780.492.8306

Other Identifiers

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Pro00122929

Identifier Type: -

Identifier Source: org_study_id

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