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The study on the performance of targeted next-generation sequencing pathogen detection in reproductive tract

Research on the Diagnostic Performance of Reproductive Tract Infection Diseases Based on Targeted Pathogen Detection Methods

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104642
Enrollment
Unknown
Registered
2025-06-20
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Reproductive tract infectious diseases

Interventions

Gold Standard:The Nugent score result should be given priority. For samples with intermediate scores of 4 to 6, the Amsel result should be used for supplementary correction. If the tNGS test result is

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
22 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.Age: 22 - 55 years old; 2.With sexual history; 3.Premenopausal; 4.After the completion of clinical testing for the clinical gynecological reproductive tract microecological detection project, if the remaining sample is more than 0.5 mL, it will be numbered after removing the patient's name, medical record number and other traceable patient identifiers. The following clinical information will be collected: gender, age, test date, clinical diagnosis, and other clinical routine reproductive tract test results; 5.Each clinical institution participating in the research will continuously collect prospective samples until the required sample size for the study is reached.

Exclusion criteria

Exclusion criteria: 1.Diseases that do not meet the criteria for pathogen screening: such as non-genital tract infection-related diseases, or other non-sexually transmitted diseases; 2.Use of douches, vaginal deodorants or vaginal products within 48 hours after enrollment or before enrollment; 3.Patients with a history of systemic organic diseases or mental disorders.

Design outcomes

Primary

MeasureTime frame
Nugent Score results;HPV nucleic acid test results;Candida nucleic acid test results;Nucleic acid test result for Neisseria gonorrhoeae;Chlamydia trachomatis nucleic acid test result;Nucleic acid test result for Treponema pallidum;Trichomonas nucleic acid test result;Clinical diagnosis include bacterial vaginitis or not;

Countries

China

Contacts

Public ContactHui Wang

Peking University People's Hospital

whuibj@163.com+86 186 1050 3998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026