49 H2Oil2 study protocol 3 Societal costs will be measured using digital iPCQ questionnaires after six months of follow-up (24). Cost categories that will be included are: (1) healthcare costs (primary and secondary care, complementary care and home care); (2) lost productivity costs (absenteeism from paid and unpaid work, and presentism) and (3) patient costs (informal care and other care services paid for by patients themselves). Valuation for participants from the Netherlands and the United Kingdom will be according to their respective national guidelines (25, 26). For the valuation of health care utilization, lost productivity and informal care, standard costs for the Netherlands and the United Kingdom will be used. Medication use will be valued using prices of the Royal Dutch Society for Pharmacy (www.KNMP.nl) and the NICE British National Formulary (www. bnf.nice.org.uk). Patient and family costs other than informal care will be valued using self-reported prices. For the valuation of absenteeism from paid work, the friction cost approach will be used. Safety monitoring The IRB determined that the study related risk for participants is very low. A Data Safety Monitoring Committee was therefore not deemed necessary. An interim analysis is not planned. All adverse events (AEs) occurring within one month after HSG will be reported to the IRB by line listing yearly. Additionally, adverse neonatal outcomes such as a congenital anomaly or birth defect will be reported as severe adverse events (SAEs). SAEsoccurring within one month after HSG will be reported to the IRB immediately through the Dutch national web portal ToetsingOnline. SAEs occurring in participants outside of the Netherlands will additionally be processed according to local regulations. All SAEs will be followed until they have abated, until a stable situation has been reached or the patient was discharged. Data management and monitoring Patient information will be filled in anonymously based on randomization number. Linking personal data to the study number can only be performed in the local participating centres. Written informed consent forms are stored in the local participating centre, all forms and data will be archived for 25 years in the participating centres according to GCP and local regulations. Monitoring of study processes will be done according to national and international guidelines by an independent study monitor (27). Annual safety reports will be sent to the accredited IRB and the competent authority. See Supplementary Table 1 for the completed WHO Trial Registration Data Set (28).
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