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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05244967
Other study ID # 20-022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 11, 2020
Est. completion date June 30, 2029

Study information

Verified date November 2023
Source University of Luebeck
Contact Nadja Käding, Dr.
Phone +4945131019010
Email nadja.kaeding@uksh.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A longitudinal study to investigate the prevalence of sexually transmitted infections among young women and determine the role of the female genital tract microbiome in fertility


Recruitment information / eligibility

Status Recruiting
Enrollment 533
Est. completion date June 30, 2029
Est. primary completion date December 31, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 22 Years
Eligibility Inclusion Criteria: - 18-22 years - informed consent Exclusion Criteria: - pregnancy - sterilization - not capable of giving informed consent

Study Design


Intervention

Other:
vaginal swab
self-sampling, vaginal swab

Locations

Country Name City State
Germany Klinik für Infektiologie und Mikrobiologie Lübeck

Sponsors (1)

Lead Sponsor Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of young women with STIs longitudinal analysis of STIs and the female genital tract microbiome at enrollment
Primary monitoring of STIs and their impact on infertility obtain a better understanding for the emergence of infectious infertility and the impact on the pathogenicity through study completion, an average of 5 years
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