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Examining HPV infection and genital microecology in women of childbearing age in China

HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study

Observational Zhujiang Hospital · NCT04694495

This study is testing how HPV infection and the balance of bacteria in the vagina affect women of childbearing age in China.

Quick facts

Study typeObservational
Enrollment10000 (estimated)
Ages18 Years to 50 Years
SexFemale
SponsorZhujiang Hospital Academic / other
Locations42 sites (Hefei, Anhui and 41 other locations)
Trial IDNCT04694495 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between genital microecology, HPV infection, and cervical intraepithelial neoplasia among childbearing-age females in China. Volunteers will be recruited from women undergoing thinprep cytologic tests and will complete a questionnaire before providing cervical and vaginal swabs for 16S rRNA gene sequencing and HPV detection. If abnormalities are found, further examinations such as vaginoscopy and cervical biopsy may be conducted. Participants will return after six months for follow-up sampling and testing.

Who should consider this trial

Good fit: Ideal candidates are sexually active females of childbearing age who are undergoing thinprep cytologic tests.

Not a fit: Patients who have had recent pregnancies, cervical surgeries, or HPV vaccinations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of HPV infection dynamics and improve screening and treatment strategies for cervical neoplasia.

How similar studies have performed: Other studies have shown promising results in understanding the link between HPV and cervical health, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Female of childbearing age conducting thinprep cytologic test
* Having an experience of sexual intercourse
* Not during the menstrual period
* No sexual intercourse or vaginal medication or vaginal flushing in 3 days before sampling

Exclusion Criteria:

* Within 8 weeks of pregnancy or postpartum
* Having had tumors in reproductive tract
* Having had HPV bivalent, tetravalent or nine-valent vaccination
* Having received treatment for anti- HPV or other STDs pathogens infection
* Having had hysterectomy, cervical surgery and pelvic radiotherapy
* Having used broad-spectrum antibiotics, probiotics or vaginal suppositories in reproductive tract within 1 month

Where this trial is running

Hefei, Anhui and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Papillomavirus InfectionsUterine Cervical NeoplasmsSexual Transmitted Disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.