Kimmy Rosielle

46 Chapter 3 Pre- and post-HSG use of analgesics and antibiotics, and subsequent management will be performed according to local protocol. Women will receive the adjusted Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire prior to their HSG procedure to score their anxiety score prior to HSG and to be able to relate this to their pain level during HSG (19). Immediately after the procedure they will be asked to score their pain using a Visual Analogous Scale (VAS) ruler (ranging from 0.0 to 10.0 cm). The choice of fertility treatments will be based on the results of the fertility work-up (including the outcome of the HSG) according to the Dutch fertility Guideline or the Clinical guideline by the National Institute for Healthcare and Excellence (NICE) (4, 2022). Anovulatory women will be offered ovulation induction, and women aged 39 years or older may be offered Intra Uterine Insemination (IUI) or In Vitro Fertilization (IVF). In case of suspected uni- or bilateral tubal pathology, women can be scheduled for IVF or a diagnostic or therapeutic laparoscopy followed by IVF if bilateral tubal occlusion is confirmed, according to the local protocol of the participating centres. Women with a high risk for tubal pathology, but without tubal pathology at HSG or laparoscopy, and with a regular menstrual cycle who are below 39 years of age will be advised expectant management or IUI, guided by their calculated prognosis for natural conception using the model of Hunault or other local protocols (23). For women aged 39 or over, the Hunault prognostic model is not verified and these women will often be advised IUI or IVF immediately. As the compared strategies (HSG with oil-based contrast versus HSG with water-based contrast) are already applied in current practice, no additional risks or burdens are expected for participating women. Outcomes The primary outcome of this trial is ongoing pregnancy leading to live birth, with conception within six months after randomization. Ongoing pregnancy will be defined as an intrauterine pregnancy with heartbeat on ultrasound examination at twelve weeks of gestation, live birth as a live born neonate beyond 24 weeks of gestation. Secondary outcomes will include clinical pregnancy (ultrasound confirmed intrauterine gestational sac), ongoing pregnancy, miscarriage (loss of clinical or ongoing pregnancy or diagnosis of a pregnancy without positive foetal heartbeat before twelve weeks gestation), ectopic pregnancy (ultrasound or surgically confirmed extra-uterine pregnancy). Pregnancy complications, complications of HSG such as intravasation, infection and hypo- or hyperthyroidism, and a cost-effectiveness analysis will also be part of the secondary outcomes. Our hypothesis is that HSG with oil-based contrast will increase ongoing pregnancy rates and will reduce time to ongoing pregnancy in all three subgroups,

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