The value of Chlamydia trachomatis-

specific IgG antibody testing and

hysterosalpingography for predicting tubal
pathology and occurrence of pregnancy

Fertility and sterility volume 88 no. 1 July 2007

INTRODUCTION
 Tubal pathology accounts for approximately
14%  causes of subfertility
 Gold standard : laparoscopy and dye test
 Several diagnosis test  assess tubal
status
 CAT (chlamydial antibody testing)
 HSG
INTRODUCTION
 The aim :
 Assessed diagnostic accuracy of CAT and
HSG compared with laparoscopy + dye
 Prognostic value of both tests to assess
occurrence of pregnancy
 MULTICENTER, RCT
 PERFORMANCE OF HSG AS ROUTINE
INVESTIGATION IN FERTILITY

Recruitment strategy
Description of subjects
 Published elsewhere
Division of Reproductive Medicine
Leiden University
178 subjects

65 88
25
HSG + Laparoscopy
HSG only
laparoscopy only
153
CTSIgG +/- CTSIgG +/-

STAGE 1
CTSIgG VS LAPAROSCOPY AND DYE
DIAGNOSTIC TEST
HSG VS LAPAROSCOPY AND DYE
STAGE 2

CTSIgG
PROGNOSTIC TEST
PREGNANCY
HSG
18 MONTHS
 DIAGNOSTIC TESTS 2 x 2 tables

LAPAROSCOPY AND DYE

Abnormal (A) : one / both tube occlusion
or peritubal adhesion
Normal (B) : no occlusion

HSG
Abnormal (A) : occlusion on one or both tubes
Normal (B) : no occlusion

CHLAMYDIA TRACHOMATIS SPECIFIC IgG (CTIgG)

Positive (A)
Negative (B)
 DIAGNOSTIC TESTS

Laparoscopy Positive likelihood ratio : 2.6

A B Negative likelihood ratio : 0.7

A 14 21 35
CTSIgG
B 17 101 118
31 121 153

SENSITIVITY : 14 / 31 = 45 %

SPECIFICITY : 101 / 121 = 83 %

 DIAGNOSTIC TESTS

Laparoscopy Positive likelihood ratio : 2.6

A B Negative likelihood ratio : 0.4

A 11 13 24
HSG
B 5 36 41
16 49 65

SENSITIVITY : 11 / 16 = 69 %

SPECIFICITY : 36 / 49 = 73 %
PROGNOSTIC TESTS

NO STATISTICALLY SIGNIFICANT
DIFFERENCE
found in cumulative pregnancy rate
between CtsIgG negative and positive

Hazard ratio 0.73

95% CI 0.42 – 1.25
p =.25
PROGNOSTIC TESTS

NO STATISTICALLY SIGNIFICANT
DIFFERENCE
in cumulative pregnancy rate between
normal and abnormal HSG

Hazard ratio 1.33

95% CI 0.73 – 2.41
p =.35
CONCLUSION
 Diagnostic accuracy of CAT antibody testing is
comparable with HSG but both show poor
performance
 The prognostic value of occurrence pregnancy of
both tests is also poor
 Chlamydia antibody testing as screening test to
estimate the risk of tubal pathology before
laparoscopy is preferable to HSG owing to its
simplicity and limited inconvenience.
General comment
 The CAT and HSG tests provide risk estimates
of tubal pathology before laparoscopy
 The diagnostic accuracy of CAT and HSG
compared with laparoscopy and dye is well
established
 The prognostic value of both studies in
predicting occurrence of pregnancy is not well
known
General comment
 Main strength : prospective study
 Shortcoming : diagnostic or prognostic value of
CAT and HSG can be determined separately, but
the total sample size is too small for the
combination of diagnostic and prognostic value
Critical Appraisal
Diagnostic study
1. Was there an independent, “blind” comparison with a gold
standard of diagnosis?
there were a gold standard involved and mentioned in this study
which was a laparoscopy + dye, but its blinding procedure did not
clearly described

2. Did the patients sample include an appropriate spectrum of

mild, severe, treated, and untreated disease, plus
individuals with different but commonly confused disorders?
there were no clear definition regarding the “state” of infertility
studied
Critical Appraisal
3. Was the setting for the study, as well as the filter through
which study patients passed, adequately described ?
The setting took place in the Division of Reproductive Medicine,
Department of Gynecology, Leiden University Medical Center

4. Was the reproducibility of the test result (precision) and

site interpretation (observer variation) determined ?
maybe, in this journal we can find “clear and fixed category /
interpretation” regarding every variables studied,
but because there was no statement about inclusion and
description of subjects somehow made it, a little bit difficult to do
Critical Appraisal
5. Was the term normal defined sensibly ?
yes both including a clear definition on its normal and
abnormal, also positive and negative result

6. If the test is advocated as part of cluster or sequence

test, was its contribution to the overall validity of the
cluster or sequence determined ?
no, it wasnt
Critical Appraisal
7. Were the tactics for carrying out the test described in
sufficient detail to permit their exact replication ?
yes, we could actually track back the result and its
interpretation with this journal

8. Was the “utility” of the test determined ?

yes, its clearly stated its aim
Critical Appraisal
Prognostic study
1. Was an inception cohort assembled ?
this study didn’t clearly stated its “baseline” condition of their
subject
2. Was the referral pattern described ?
no

3. Was the complete follow up achieved ?

yes, it mentioned 0% loss to follow up
Critical Appraisal
4. Were objective outcome criteria developed and used ?
yes, it were positive urine or serum pregnancy test in
association with an intact intrauterine gestation sac on
ultrasound

5. Was the outcome assessment “blind” ?

didn’t state clearly
 Validity
its validity regarding, procedure, subjects recruitment,
confounding factor and person who assessed the variables and
outcome criteria didn’t mentioned clearly  questionable

 Expertise
its results were almost similar to other study previously carried
out

 Applicable to clinic / practice

able to be include in part of our systematic assessment of
patient but cannot be done as a single examination alone due to
its poor performance and predictive value