Endometriosis Clinical Trial
Official title:
CA 125 and VAS Pain Score Changes Following GnRH-analog Administration as ex Adiuvantibus Criteria to Diagnose Endometriosis as Cause of Chronic Pelvic Pain.
To assess the diagnostic accuracy for the noninvasive detection of pelvic endometriosis of the combination of two simple parameters: modifications of serum CA 125 and VAS pain score following one dose of GnRH-analog (GnRH-a).
Between January 2010 and January 2014, women scheduled for a diagnostic laparoscopy for CPP
at our Department will be enrolled in the current prospective observational study. For these
patients, laparoscopy represents the last diagnostic step after medical history negative for
gastrointestinal, urological, musculoskeletal and psychoneurological disorders related to
pelvic pain, physical examination, ultrasonographic assessment and laboratory testing. From
all patients, at enrollment, blood samples for serum CA125 determination will be taken
during the early follicular phase (2nd-3rd day of the menstrual cycle) and VAS score for
menstrual pain will be assessed. Electrochemiluminescence immunoassay (Immunoassay Elecsys
Systems, Roche Diagnostics, Italy) for serum CA125 assay will be used (kit coefficient of
variation between-run 0.0% and within-run 2.0%).
During the time passed on surgery waiting list, patients will received leuprolide acetate
depot (LAD) at a dose of 3.75 mg IM at the 21st day of the menstrual cycle. One month later
LAD administration, serum CA125 levels and VAS score will be assessed again, and then the
surgical procedure will be performed in all these patients.
After laparoscopy and definitive histological examination, the population initially enrolled
will be sub-grouped according to endometriosis diagnosis in two groups, i.e. group 1
(subjects with endometriosis) and group 2 (subjects without endometriosis).
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Observational Model: Cohort, Time Perspective: Prospective
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