Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hystero… (NCT05419921) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing
Stopped: The data collection team stopped recruiting cases.
Egypt122 participantsStarted 2018-02-01
Plain-language summary
This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Age group (18-40)
✓. Informed signed Written consent.
✓. Scheduled for LDT as a part of their infertility management
✓. Have undergone HSG in the previous 5 years with the availability of good-quality HSG images.
✓. No incident factors that might have affected the tubal status after she underwent HSG within the previous 5 years, such as ; abdominal surgery or laparoscopy, pelvic inflammatory disease, smoking, and intrauterine device insertion.
Exclusion criteria
✕. LDT scheduled for a therapeutic purpose due to a known tubal or ovarian pathology
✕. Lack of good-quality HSG images.
✕. Withdrawal of consent.
✕. Using contraception
✕. Women outside reproductive age
What they're measuring
1
Diagnostic accuracy of HyLiFoSy and HSG with reference to LDT, in terms of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy.