47 H2Oil2 study protocol 3 thereby reducing the need for assisted reproductive technology (ART) and thus lowering the costs. In addition, we will study the procedural discomfort or pain and relate this to pre-procedural anxiety, using a modified APAIS questionnaire (19). Follow‑up Data on fertility treatments and pregnancy outcomes will be collected until six months after randomization in a structured electronic case report form using Castor EDC. If a pregnancy occurs within six months, the outcome of the pregnancy will be followed. If the necessary information cannot be extracted from the medical record, women will receive a digital questionnaire about treatment and pregnancy outcomes or they will be contacted by a dedicated researcher to conduct the follow-up questionnaire by phone. All participating women will receive a digital questionnaire on productivity-loss and health care costs (iPCQ) six months after randomization (24) (see Table 1). Table 1. SPIRIT figure. t−1: Prior to inclusion; t0: Study inclusion; t1: HSG procedure, usually within 4 weeks of inclusion (t0); t2: end of initial follow-up 6 months after randomization; t3: pregnancy followup, at last 9 months after t2. Study Period Enrolment Allocation Post-allocation Time-point t-1 t0 t1 t2 t3 ENROLMENT Eligibility screen X Informed consent X Allocation X INTERVENTIONS HSG with oil-based contrast X HSG with water-based contrast X ASSESSMENTS Demographics X APAIS X Pain score (VAS) X HSG procedure and results X Adverse effects X iPCQ X Treatments X Pregnancies X Pregnancy follow-up X
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