Diagnostic accuracy of hysterosalpingo-lidocaine-foam sonography combined with power Doppler (HyLiFoSy-PD) compared to laparoscopy and dye testing in tubal patency assessment in cases of infertility

Abstract

Abstract Background Tubal patency testing is an essential part of female subfertility evaluation. Hysterosalpingogram is less invasive and less expensive compared to laparoscopy and dye testing (LDT), i.e., laparoscopic chromopertubation. Hysterosalpingo-foam sonography (HyFoSy) uses commercial echogenic gel foam that is easily visible on ultrasound to assess the tubes. It offers a safer and less painful alternative to HSG, with no radiation exposure. Hysterosalpingo-lidocaine-foam sonography with power Doppler (HyLiFoSy-PD) uses lidocaine-made gel foam as a contrast medium. It was postulated to as to be less painful and easier to detect on ultrasound, compared with hysterosalpingo-foam sonography using other contrast media and that it can also be used whenever the commercial gel used with HyFoSy is not available or is relatively expensive. Methodology This prospective diagnostic accuracy study was carried out between February 2018 and 2020 at the Cairo Fetal Medicine Unit, Department of Obstetrics and Gynecology, Cairo University. One hundred twenty-two infertile patients, who were already scheduled for LDT as a part of their infertility work-up, were consecutively recruited for this study. The HyLiFoSy-PD (index test) was performed 1 week before the scheduled LDT for these patients. Using an intrauterine pediatric Folley’s balloon catheter, 20 ml of lidocaine-made gel foam was slowly infused intrauterine, while observing their flow in both fallopian tubes using a grayscale and power Doppler transvaginal two-dimensional ultrasound system. All patients then underwent LDT (reference test). The results of HyLiFoSy-PD were compared with those of LDT to determine the accuracy of HyLiFoSy-PD in tubal patency assessment. We also assessed the procedure duration, associated pain, and other complications. Results Comparing HyLiFoSy-PD with LDT in the 115 patients who completed the procedure, results showed 98.1% sensitivity, 90% specificity, 99% positive predictive value, 81.8% negative predictive value, 9.81 positive likelihood ratio, 0.02 negative likelihood ration, and 97.4% overall accuracy in the assessment of tubal patency (odds ratio = 463.5 with confidence interval = 79.39–2706; P-value: 0.687). The median procedure duration was 11 min. All patients experienced some degree of pain during the procedure with 91 patients (79%) reported mild pain and 24 patients (21%) reported moderate pain. Conclusion HyLiFoSy-PD was found to be an accurate tool in tubal patency assessment. It was also found to be safe and well-tolerated.