Sexually Transmitted InfectionESTIMATENCT05244967
Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility
An observational study of Sexually Transmitted Infection, run by University of Luebeck at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infection
- What is being tested?
- vaginal swab
- How many people
- 533 participants
- Where
- 1 siteGermany
- Study dates
- 11 Nov 2020to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 22 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Young women aged 18-22 years.
Who may be able to join
- 18-22 years
- informed consent
Who cannot join
- pregnancy
- sterilization
- not capable of giving informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Infektiologie und Mikrobiologie
Lübeck
Nadja Käding
About this study
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
- Conditions
- Sexually Transmitted Infection
- Being tested
- vaginal swab
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal swabOther
self-sampling, vaginal swab
What is being measured
The primary outcome is the main question the study is designed to answer.
number of young women with STIs
longitudinal analysis of STIs and the female genital tract microbiome
Measured: 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
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start11 Nov 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 533 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Käding, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244967
- Sponsor's protocol ID
- 20-022
- Acronym
- ESTIMATE
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2022
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility
- ClinicalTrials.gov ID
- NCT05244967
- Acronym / sponsor ID
- ESTIMATE / 20-022
- Conditions
- Sexually Transmitted Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 533 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Feb 2022 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young women aged 18-22 years.
Key inclusion criteria (2 listed)
- 18-22 years
- informed consent
Key exclusion criteria (3 listed)
- pregnancy
- sterilization
- not capable of giving informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal swabself-sampling, vaginal swab | Other | – |
Primary outcome
number of young women with STIs
Time frame: at enrollment
longitudinal analysis of STIs and the female genital tract microbiome
monitoring of STIs and their impact on infertility
Time frame: through study completion, an average of 5 years
obtain a better understanding for the emergence of infectious infertility and the impact on the pathogenicity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Infection, run by University of Luebeck at 1 site in Germany.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadja Käding, Dr. (+4945131019010, nadja.kaeding@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of young women with STIs (time frame: at enrollment). The study lists 2 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 30 Apr 2026.