This Cochrane review evaluated the diagnostic accuracy of various hysterosalpingography techniques for identifying tubal occlusion and hydrosalpinx. The analysis included 1939 participants who had been trying to conceive for at least one year. The setting was not reported for the included studies. The primary index tests included sono-HSG, HSG, THL, and MR-HSG, though MR-HSG data was insufficient for meta-analysis. The reference standard was laparoscopy with methylene blue dye tubal patency testing.
The review assessed diagnostic performance for bilateral tubal occlusion using sono-HSG. Sensitivity was 0.98 with a 95% CI of 0.19 to 1.00 based on 259 women. Specificity was 0.99 with a 95% CI of 0.93 to 1.00 for the same group. For standard HSG, sensitivity for bilateral tubal occlusion was 0.77 with a 95% CI of 0.58 to 0.89 among 670 women. Specificity for HSG was 0.94 with a 95% CI of 0.87 to 0.97 in this cohort.
Diagnostic accuracy for hydrosalpinx was also examined. HSG showed a sensitivity of 1.00 with a 95% CI of 0.96 to 0.98 for 360 tubes. Specificity for hydrosalpinx diagnosis by tube was 0.96 with a 95% CI of 0.96 to 0.98. THL results for bilateral tubal occlusion showed a sensitivity of 0.95 with a 95% CI of 0.30 to 1.00 in 172 women. Specificity for THL was 0.99 with a 95% CI of 0.84 to 1.00.
Safety and tolerability data were not reported for adverse events, serious adverse events, discontinuations, or general tolerability. The certainty of evidence ranged from very low to high. Heterogeneity concerning population characteristics and index test characteristics was noted as a significant factor. Limited reporting on population risk and operator experience may reduce the generalisability of the findings to routine clinical practice.
Unclear or high risk of bias was identified in the included studies. Imprecision was another limitation. Insufficient information on operator skills and patient risk stratification further constrained the interpretation. Evidence for comparative diagnostic accuracy studies is very limited. We did not include any studies on the diagnostic accuracy of MR-HSG. We were unable to perform meta-analysis on the diagnosis of hydrosalpinx.
Clinical implications suggest that HSG and sono-HSG are viable options for diagnosing tubal pathology. However, operator experience and patient risk stratification remain unclear. Questions remain regarding the generalisability of findings to routine practice. The review had no dedicated funding. Further research is needed to address heterogeneity and bias risks in diagnostic accuracy studies for tubal factors.
View Original Abstract ↓
BACKGROUND: Around 18% to 33% of couples with infertility present with tubal occlusion (blocked or damaged fallopian tubes) or hydrosalpinx (fluid-filled tubes). Diagnostic laparoscopy (keyhole surgery) with chromopertubation (methylene blue dye tubal patency testing) is considered the reference standard for ruling out tubal occlusion and hydrosalpinx. However, due to its invasiveness and high costs, alternative, less invasive tests have been carried out using imaging techniques. They include sono-hysterosalpingography (sono-HSG), hysterosalpingography (HSG), outpatient transvaginal hydrolaparoscopy (THL), and magnetic resonance hysterosalpingography (MR-HSG). The choice of test varies in different settings; the choice of contrast, operator skill and test technology are factors that can influence diagnostic quality. Furthermore, the performance of the visual tubal patency tests can vary in different populations, depending on whether the test is carried out in an unselected group or in one classified as high or low risk for having tubal pathology.
OBJECTIVES: To determine and compare the diagnostic accuracy of visual tubal patency tests (sono-HSG, HSG, THL, and MR-HSG) for the diagnosis of tubal occlusion. Secondary objectives are to determine and compare the diagnostic accuracy of visual tubal patency tests (sono-HSG, HSG, THL, and MR-HSG) for the diagnosis of hydrosalpinx and to evaluate heterogeneity concerning population characteristics (population risk stratification) and index test characteristics (contrast media, technology, operator skills).
SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and CINAHL, and two trials registers. We also contacted experts in the field for any additional studies (last date of search: 6 November 2023).
SELECTION CRITERIA: We included studies on the diagnostic accuracy of a single index test and studies on the comparative diagnostic accuracy of two or more index tests. Index tests included were: sono-HSG, HSG, THL, and MR-HSG. Laparoscopy with methylene blue dye tubal patency testing was the reference standard. We included participants who had been trying to conceive for at least one year. All participants in the included studies should have undergone this reference standard. Target conditions were bilateral tubal occlusion, at least one-sided tubal occlusion, tubal occlusion by tube, and hydrosalpinx.
DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We performed random-effects meta-analysis in a bivariate model. For each index test, we presented pairs of sensitivity and specificity with their 95% confidence intervals (CIs) for each study, as well as the pooled sensitivity and specificity in a forest plot. We used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool for risk of bias assessments.
MAIN RESULTS: We identified 11,787 records and included 21 studies (1939 participants). Two studies directly compared both sono-HSG and HSG to the reference test, while the other 19 reported on the diagnostic accuracy of one of the index tests (10 on sono-HSG, 10 on HSG, and 3 on THL). We did not include any studies of MR-HSG. Sono-HSG: for bilateral tubal occlusion, the pooled sensitivity was 0.98 (95% CI 0.19 to 1.00; 3 studies, 259 women; moderate-certainty evidence) and specificity was 0.99 (95% CI 0.93 to 1.00; 4 studies, 259 women; high-certainty evidence). Subgroup analyses showed that colour Doppler was associated with higher specificity than standard ultrasound, but with similar sensitivity. We did not find differences in diagnostic accuracy in the use of 3-dimensional/2-dimensional or 2-dimensional ultrasound, or the use of foam or saline as contrast media. We were unable to perform meta-analysis on the diagnosis of hydrosalpinx. HSG: for bilateral tubal occlusion, the pooled sensitivity was 0.77 (95% CI 0.58 to 0.89; 7 studies, 670 women; very low-certainty evidence) and the pooled specificity was 0.94 (95% CI 0.87to 0.97; 7 studies, 670 women; moderate-certainty evidence). For hydrosalpinx by tube, the pooled sensitivity was 1.00 and specificity was 0.96 (95% CI 0.96 to 0.98; 2 studies, 360 tubes). THL: for bilateral tubal occlusion, the pooled sensitivity and specificity were 0.95 (95% CI 0.30 to 1.00; 3 studies, 172 women; low-certainty evidence) and 0.99 (95% CI 0.84 to 1.00; 3 studies, 172 women; moderate-certainty evidence), respectively. We were unable to perform meta-analysis on the diagnosis of hydrosalpinx. There was insufficient information on operator skills and patient risk stratification for all index tests to carry out further analyses.
AUTHORS' CONCLUSIONS: The evidence showed that sono-HSG, HSG and THL are all reliable tests for the diagnosis of double-sided tubal occlusion. Evidence for comparative diagnostic accuracy studies is very limited. We did not include any studies on the diagnostic accuracy of MR-HSG. The certainty of evidence ranged from very low to high. This was mainly due to unclear or high risk of bias, heterogeneity and imprecision. Limited reporting on population risk and operator experience may reduce the generalisability of the findings to routine clinical practice.
FUNDING: This Cochrane review had no dedicated funding.
REGISTRATION: Protocol (2022) available via: https://doi.org/10.1002/14651858.CD014968.
