Abstract

Abstract Study question To assess whether Hystero-salpingo-Foam Sonography (HyFoSy) is an effective and feasible alternative to X-ray Hystero-Salpingo-Graphy (HSG) and Hystero-salpingo-Contrast Sonography (HyCoSy) in fallopian tube patency assessment. Summary answer HyFoSy demonstrated significantly superior diagnostic sensitivity and specificity compared to HyCoSy, however only demonstrated minimal diagnostic agreement with HSG. What is known already Tubal pathology is a contributing factor in up to 35% of infertility cases, a fact which renders accurate and clinically applicable tubal patency assessment a vital component of the infertility workup. Currently, the most widely utilized methods of assessment are HyCoSy and HSG, which, while effective, do possess certain disadvantages. HyFoSy is an alternative to the aforementioned assessment test, utilizing a specially developed contrast agent, which may offer comparable diagnostic efficacy without the associated disadvantages of the other two methods. Study design, size, duration Relevant studies were systematically searched for in the Scopus, Pubmed and Web of Science online peer-reviewed databases. The resulting studies were systematically assessed based on pre-established inclusion criteria (PICOS format) according to the PRISMA algorithm for systematic reviews. The included studies were assessed for risk of bias using a modified version of the QUADAS-2 tool and relevant data was extracted and meta-analysis of diagnostic performance data was conducted. Participants/materials, setting, methods This analysis included data from 5 studies and 1433 patients, with 2336 tubes being eligible for inclusion. Data extracted regarding primary outcomes were true positive, false positive, false negative and true negative number of patients for studies that used a reference test and sensitivity and specificity could be calculated. For studies that assessed inter-method agreement, raw data on the number of patients with method agreement and disagreement was extracted and Cohen’s k values were calculated. Main results and the role of chance With regard to HyFoSy and HyCoSy comparison, pooled sensitivity was 87% and 69% respectively, with the difference being statistically significant (p = 0.037), while pooled specificity was 95% and 85% respectively, with the difference being statistically significant (p < 0.001). Regarding the HyFoSy and HSG comparison, the pooled Cohen’s k statistic resulting from the meta-analysis was 0.39 ; this is interpreted as fair to minimal overall diagnostic agreement between HyFoSy and HSG. Regarding procedure-associated patient pain, HSG was 6.5 times more painful (OR = 6.57, CI 95% 3.11–13.89) compared to HyFoSy and the former was graded at 5.4 ± 2.5 on a 10-point scale compared to the latter that was graded at 3.1 ± 2.2 (p < 0.001), a difference that was statistically significant. Limitations, reasons for caution The small number of available comparative studies on HyFoSy, the lack of studies that used a reference standard for the comparison of HyFoSy to HSG and the observed statistical heterogeneity, may have introduced a degree of bias in the results if this analysis. Wider implications of the findings HyFoSy, being less painful than HSG and more reliable in diagnosing patency, may be applicable as a first line diagnostic test, with HSG reserving its value in the evaluation of abnormal and/or unclear results as a second line test. Trial registration number not applicable

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