Vaginal InfectionVENUSNCT05997160
Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
An observational study of Vaginal Infection, run by Tianjin Medical University General Hospital.
Trial summary
The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Infection
- How many people
- 5,590 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: VENUS study plans to enrol 5590 participants, aged 15-49 years, from visiting our research settings across the country who evaluate vaginal discharge based on Gram-stained smear.
Who may be able to join
- Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear.
- No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours.
- Not during menstruation (menstrual period ended ≥3 days ago).
Who cannot join
- Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.
Read the detailed description
This study consists of two sub-studies:
- Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy.
- Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.
- Conditions
- Vaginal Infection
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hospital name + infection type + number | There is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score for smear
This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.
Measured: December 2023
Diagnosis of vaginitis type
The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal.
Measured: March 2024
Relative Abundance
Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.
Measured: May 2024
Intensity
The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.
Measured: May 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Bioperfectus Technologies Co., Ltd
- Responsible party
- Principal investigator, Fengxia Xue, Tianjin Medical University General Hospital
- Investigators
- Fengxia Xue, PhD, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997160
- Sponsor's protocol ID
- IRB2023-YX-022-01
- Acronym
- VENUS
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Vaginal Microbiota Evaluation Unified Standards Based on Gram Staining
- ClinicalTrials.gov ID
- NCT05997160
- Acronym / sponsor ID
- VENUS / IRB2023-YX-022-01
- Conditions
- Vaginal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,590 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Bioperfectus Technologies Co., Ltd
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to explore a standardized sample process for improving the accuracy of vaginal microbiota evaluation and to explore a more complete and comprehensive method for vaginal microbiota evaluation based on gram staining.
Detailed description
This study consists of two sub-studies:
- Sub-study on Standardized method of Microscopic Slide Preparation: this sub-study aims to compare different slide preparation methods and dilution levels based on various aspects, including uniformity, impurities, clarity and so on, and then explore the optimal method and dilution level. Additionally, it will summarize the conversion method for white blood cells between wet mount and gram staining, and for white blood cells between high-power microscopy and oil immersion microscopy.
- Sub-study on Vaginal Microbiota Evaluation on Gram Staining: For patients with diagnosed vaginal infection type, it will calculate the consistency of results between different laboratories. And it will evaluate the effectiveness combined artificial intelligence technology and other technological platforms. Besides, for patients without diagnosed vaginal infection type, different methods such as 16S rRNA gene sequencing and metagenomic sequencing are used for analysis and profiling to guide treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hospital name + infection type + number | – | –There is no intervention. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- VENUS study plans to enrol 5590 participants, aged 15-49 years, from visiting our research settings across the country who evaluate vaginal discharge based on Gram-stained smear.
Key inclusion criteria (3 listed)
- Non-pregnant women who visit our research settings and conduct vaginal discharge examination based on Gram-stained smear.
- No sexual intercourse, vaginal douching, or vaginal medication within the last 72 hours.
- Not during menstruation (menstrual period ended ≥3 days ago).
Key exclusion criteria (1 listed)
- Receiving systemic or vaginal antifungal or antibiotic treatment within the past week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The score for smear
Time frame: December 2023
This score consists of uniformity, impurities, cell degeneration, and clarity for evaluating a smear.
Diagnosis of vaginitis type
Time frame: March 2024
The Diagnosis of vaginitis type based on Gram-stained smear and antigen testing, including aerobic vaginitis(AV), bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), and normal.
Relative Abundance
Time frame: May 2024
Relative Abundance is from 16S rRNA gene sequencing and metagenomic sequencing for patients without clearly diagnosis.
Intensity
Time frame: May 2024
The intensity is tested by liquid chromatography-tandem mass spectrometry for targeted metabolites for patients without clearly diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengxia Xue, PhD principal investigator
Tianjin Medical University General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Infection, run by Tianjin Medical University General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengxia Xue, PhD (8615022655806, qiwenhui1987@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score for smear (time frame: December 2023). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.