Abstract

Background and Aims: Tubal patency assessment is an important part of routine infertility work-up. It has been suggested that hysterosalpingography should no longer be considered as a ‘first line’ diagnostic procedure. We aimto determine the accuracy of an alternative technique, hysterosalpingo-foam sonography (HyFoSy), in tubal patency assessment in infertile women. Methods: This prospective study was conducted at My Duc Hospital and was approved by the institutional ethics committee (25/2019/MD). Infertile women who were scheduled for undegoing laparoscopy during infertility investigation. A visual analogue scale (VAS) score for perception of pain during HyFoSy was used. Laparoscopywith dye chromotubation, was performed on the same day and used as a gold standard. Clinicians performing laparoscopy were blinded to HyFoSy results. Sensitivity, specificity, negative and positive predictive value (NPV, PPV)and 95% confidence interval (CI) were calculated. A sample size of 455 women was needed to demonstrate a non-exceeding 8% of fluctuation hypothesis of the two sensitivity and specificity (power 0.80, two-sided alpha 5%, loss to follow-up 5%). Results: Between 2019 and 2022, we recruited 455 women. Five women had inconclusive HyFoSy results, three women withdrew consents. Data analysis was performed on 447 women (868 tubes). The sensitivity and specificity of HyFoSy, as compared to laparoscopy, were 0.76 (95% CI 0.72–0.80) and 0.71 (95% CI 0.67–0.75), respectively. HyFoSy gave a PPV of 0.72 (95% CI 0.69–0.76) and a NPV of 0.75 (95% CI 0.72–0.78). 50% of women reported no pain. No adverse events were reported. Conclusion: HyFoSy is a well-tolerated, safe, and reliable technique compared to laparoscopy for tubal patency assessment.

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