83 Safety of HSG with oil-based contrast medium 5 limitations on language or publication period were applied. Colleagues who were fluent in the foreign languages assisted in translating. Outcomes The outcomes included adverse events of HSG with the use of oil-based contrast (versus water-based contrast) in subfertile women and their offspring, such as: intravasation of the contrast medium, embolization of the contrast medium, pelvic inflammatory disease, lipogranuloma formation, retention of contrast, maternal or fetal thyroid dysfunction, and anaphylactic reactions. The clinical consequences included additional treatments, hospital stay, morbidity and mortality. Study selection, data collection and quality assessment Study eligibility was evaluated by two reviewers (IR and KR) independently; disagreements between the two reviewers were solved by consensus or by consultation with another reviewer (CK) when necessary. A predesigned form was used to extract the data and assess the quality of the included studies. The following information was collected: name of the first author, publication year, study design, study population, participants’ characteristics, types of contrast, details of interventions and co-interventions, sample sizes and outcomes. Full-text articles of English cohort and randomized studies were screened by a second reviewer (KR). Risk of bias was assessed for all studies, excluding the case reports/series, in accordance with the quality assessment checklist for prevalence studies (16) (Supplementary Table 4). This checklist contains nine questions, each scored with 0 or 1 points. A total of 0–3 points is classified as an overall low risk of study bias, 4–6 points as moderate risk and 7–9 points as high risk. The risk of bias was assessed by two reviewers independently for the English studies. Statistical analysis The prevalence of complications occurring with the use of oil-based contrast was calculated, and where possible comparisons were made to the use of water-based contrast. Meta-analyses were performed using Review Manager Version 5.3. Statistical heterogeneity was estimated by performing a chi-squared test and calculating I2. Pooled weighted prevalences and the 95% CI were calculated using the MetaXL tool (Version 5.3, 2016; EpiGear International Pty Ltd, Queensland, Australia). A non-pre-specified sensitivity analysis was performed, selecting the cohorts and RCT to calculate the prevalence of complications. Case reports and case series were included to report all (and rare) complications.
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