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. 2016 May 1;2016(5):CD012179. doi: 10.1002/14651858.CD012179

Lima 2006.

Study characteristics
Patient sampling Primary objective: to determine FSH, LH, E2, progesterone, and Hi concentrations in serum, PF and FF of women with and without endometriosis
Participants: women undergoing laparoscopy for infertility and/or pelvic pain (cases) and tubal sterilisation (controls)
Selection criteria: inclusion criteria: secretory cycle phase, no medical treatment for at least three months preceding surgery, absence of other gynaecological diseases, absence of pelvic pain, age between 18 and 40 years
Study design: cross‐sectional, two‐gate design, prospective collection of samples
Patient characteristics and setting Clinical presentation: pelvic pain, infertility (cases); asymptomatic fertile women requesting sterilisation (controls)
Age: mean age 33.9 ± 7.8 years (endometriosis group), 36.8 ± 7.4 years (controls)
Number of participants enrolled: 49 women
Number of participants available for analysis: 49 women (all in luteal cycle phase)
Setting: Department of O&G, Hospital das Clinicas, Faculty of Medicine of Ribeirão Preto, University of São Paulo
Place of study: São Paulo, Brazil
Period of study: 2002‐2004
Language: Portuguese
Index tests Index test: FSH , LH, E2, progesterone
Details of the index test procedure as stated: serum concentrations of FSH, LH, E2 and progesterone were measured using a commercial kit (DPC Imm Sys, California) by chemiluminescence; sample processing described
Threshold for positive result: not provided
Examiners: no information provided; unclear if blinded to the result of reference standard
Interobserver variability: Intra‐ and interassay CV were for FSH 7.9% and 6.5%, for LH 8.8% and 11.3%, for E2 8.4% and 9.3%, for P 5.8% and 10.3%
Target condition and reference standard(s) Target condition: endometriosis
Prevalence of target condition in the sample: n = 28/49 (57%): stage I‐II 18, stage III‐IV 10; controls n = 21
Reference standard: laparoscopy n = 49 (100%)
Description of positive case definition by reference standard as reported: visual inspection; staging according to the rASRM classification
Examiners: no information provided
Flow and timing Time interval between index test and reference standard: blood samples were collected before anaesthesia
Withdrawals: none
Comparative  
Key conclusions by the authors Ovary dysfunction in women with endometriosis, with reduction on E, P and Hi concentrations, which may contribute to the subfertility often associated with the disease
Conflict of interest Not reported
Notes For LH and FSH there was no statistically significant difference between the groups ‐ no data available for meta‐analysis
For E2 and progesterone there was statistically significant difference between the groups, but there was insufficient data to construct 2 x 2 tables ‐ not included in this review
The data for markers measured in peritoneal fluid are not presented in this review
Methodological quality
Item Authors' judgement Risk of bias Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled? No    
Did the study avoid inappropriate exclusions? Yes    
Was a 'two‐gate' design avoided? No    
    High High
DOMAIN 2: Index Test All tests
Were the index test results interpreted without knowledge of the results of the reference standard? Unclear    
If a threshold was used, was it pre‐specified? No    
Was a cycle phase considered in interpretation of the result of index test? Yes    
    High Low
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Unclear    
Were the reference standard results interpreted without knowledge of the results of the index tests? Yes    
    Unclear Low
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard? Yes    
Did all patients receive the same reference standard? Yes    
Were all patients included in the analysis? Yes    
    Low