Published: September 2024
My T Le 1, Binh H Vo 2, Hoa P Le 2, Anh P Pham 2, Anh L Vu 3, Toan D Pham 3, Tham T Truong 2, Tuong M Ho 4, Vinh Q Dang 5
Authors information
1Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam. Electronic address: bsmy.lt@myduchospital.vn.
2Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam.
3HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.
4Department of Obstetrics and Gynaecology, My Duc Hospital, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam.
5HOPE Research Center, My Duc Hospital, Ho Chi Minh City, Vietnam; Department of Obstetrics and Gynaecology, School of Clinical Science, Monash University, Melbourne, Australia.
Abstract
Research question: What is the diagnostic accuracy of hysterosalpingo-foam sonography (HyFoSy), using two-dimensional ultrasound in tubal patency assessment in infertile women compared with laparoscopy with dye chromotubation?
Design: This prospective study was conducted at My Duc Hospital, Vietnam. Infertile women aged 18 years or older, who were scheduled for laparoscopy, were included. Visual Analogue Scale (VAS) score for perception of pain during HyFoSy was used. Laparoscopy was carried out on the same day. Clinicians undertaking laparoscopy were blinded to HyFoSy results. Sensitivity, specificity, negative and positive predictive value, and 95% confidence intervals were calculated. A sample size of 455 women (n = 910 fallopian tubes) was needed to demonstrate a fluctuation hypothesis, not exceeding 6%, for sensitivity and specificity (power 0.80, two-sided alpha 5%, loss to follow-up 5%).
Results: Between 2019 and 2022, 455 participants were recruited. Hysterosalpingo-foam sonography was unsuccessfully carried out in six participants. Two withdrew their consent. Data analysis was conducted on the remaining 447 participants (n = 868 fallopian tubes). The sensitivity and specificity of hysterosalpingo-foam sonography compared with laparoscopy were 0.75 (95% CI 0.71 to 0.79) and 0.70 (95% CI 0.65 to 0.74), respectively. Hysterosalpingo-foam sonography gave a positive predictive value of 0.76 (95% CI 0.73 to 0.80) and negative predictive value of 0.68 (95% CI 0.64 to 0.73). A total of 42.8% of women reported a VAS score of no pain. No adverse event was reported.
Conclusion: Compared with laparoscopy with dye chromotubation, two-dimensional HyFoSy is a well-tolerated, reliable technique for assessing tubal patency.
Keywords: Hysterosalpingo-foam sonography; Laparoscopy; Tubal patency assessment.