NCT05244967

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
533

participants targeted

Target at P75+ for all trials

Timeline
38mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Nov 2020Jun 2029

Study Start

First participant enrolled

November 11, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8.1 years

First QC Date

January 27, 2022

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • number of young women with STIs

    longitudinal analysis of STIs and the female genital tract microbiome

    at enrollment

  • 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

Interventions

self-sampling, vaginal swab

Eligibility Criteria

Age18 Years - 22 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young women aged 18-22 years.

You may qualify if:

  • years
  • informed consent

You may not qualify if:

  • pregnancy
  • sterilization
  • not capable of giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Infektiologie und Mikrobiologie

Lübeck, Germany

RECRUITING

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nadja Käding, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 17, 2022

Study Start

November 11, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations