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Detection of Chlamydia trachomatis antibodies in vaginal swabs as an intermediate marker for PID and tubal pathology * pilot study

Withdrawn
Conditions
Chlamydia
PID
tubal infertility
10008555
10013356
Registration Number
NL-OMON36428
Lead Sponsor
RIVM
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
150
Inclusion Criteria

In STI-clinics: women who tested positive or negative in a PCR test for (current) genital Chlamydia trachomatis infection and are willing to participate in the study.
In fertility clinic: women who tested positive or negative with serum Chlamydia antibody test (CAT).

Exclusion Criteria

In STI clinics: women with coinfection HIV, girls under 18 years old.
In infertility clinic: women with HIV.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To compare the presence and quantity/titres of IgG antibodies findings with the<br /><br>health status of the patients regarding current (vaginal) Chlamydia infections,<br /><br>history of prior Chlamydia infections, in lower genital tract (vagina, cervix)<br /><br>or higher parts (pelvic, ovaria: PID) and fertility-related problems (tubal<br /><br>pathology).</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Depending on the outcomes of this pilot, we aim to set-up a larger study to<br /><br>investigate the prevalence of these antibodies in vaginal samples and the risk<br /><br>for PID prospectively in a dual cohort of women, screened and unscreened.</p><br>
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