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NCT00827970 Clinical Trial

Randomized Population-Based Study on Chlamydia Trachomatis Screening

Infertility Clinical Trial

Official title:
Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00827970
Other study ID # Cesoirs01
Secondary ID
Status Completed
Phase N/A
First received January 22, 2009
Last updated January 22, 2009
Start date October 1997
Est. completion date August 2007

Study information
Verified date January 2009
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.

The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.

Recruitment information / eligibility
Status Completed
Enrollment 30000
Est. completion date August 2007
Est. primary completion date February 1998
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 24 Years
Eligibility Inclusion Criteria:

- born in 1974, 1974 or 1976 AND living in Aarhus County October 1007

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Behavioral:
• Screening for urogenital Chlamydia trachomatis
Receeiving an invitation to be tested for urogenital Chlamydia trachomatis by use of a home-obtained and mailed sample.

Locations
Country Name City State
Denmark Department of Infectious Diseases, Aarhus University Hospital Skejby Aarhus N

Sponsors (4)
Lead Sponsor Collaborator
University of Aarhus Aarhus County, Denmark, Novo foundation, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Andersen B, Olesen F, Møller JK, Østergaard L. Population-based strategies for outreach screening of urogenital Chlamydia trachomatis infections: a randomized, controlled trial. J Infect Dis. 2002 Jan 15;185(2):252-8. Epub 2002 Jan 3. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Long term infertility complications 2008 No
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