Abstract

Abstract Study question Can a smartphone video clip detailing the patient journey decrease the anxiety of women and men on the day of their first oocyte aspiration? Summary answer The video clip does not affect the anxiety of women but does reduce the anxiety of men on the day of couples’ first oocyte aspiration. What is known already Infertility and in vitro fertilisation (IVF) decrease the personal wellbeing of women and men. Couples shared that this contributed to their IVF discontinuation despite a good prognosis and reimbursement of IVF. Previous longitudinal studies confirmed that pre-IVF anxiety is associated with IVF discontinuation. Limiting treatment anxiety is, therefore, relevant for fertility patients and clinics. Studies from the field of reproductive medicine examining the effect of preparatory information on anxiety suggest that focussed interventions seem more effective than complex interventions. Several randomized controlled trials (RCTs) found that preparatory information movies reduce anxiety for out-patient cardiology procedures in women and men. Study design, size, duration This monocentric RCT randomized (1:1 allocation; computerized) 190 heterosexual couples about to start their first IVF cycle between care as usual (i.e. preparatory information session 1-3 months before IVF) and care as usual combined with a novel intervention during a 24 months recruitment period (2018-2020). The novel intervention is a 5-minute smartphone video clip detailing the patient journey on the day of oocyte aspiration, which was sent to both partners the day before oocyte aspiration. Participants/materials, setting, methods Upon arrival at a private fertility clinic for their first oocyte aspiration women and men independently filled out the ‘STAI-State anxiety inventory’ and the ‘infertility distress scale (IDS)’ and evaluated the novel intervention, if applicable. A minority of randomized couples didn’t comply with the standard IVF trajectory (n = 27) or didn’t fill out the questionnaires (n = 8). The data of 155 couples (76-79/group, a-priori sample size calculation requested minimally 76/group) was subjected to a modified intention-to-treat analysis. Main results and the role of chance Women and men were on average 33 and 35 years old, respectively. Couples had a mean duration of infertility of 27 months and 63 of them (41%) had tried intrauterine insemination. The background variables were equally distributed between the intervention (IG) and control group (CG). The video clip did not affect women’s anxiety on the day of oocyte aspiration (mean STAI-State score IG 42.7±8.1 vs CG 42.1±8.5, p = 0.67). However, men who watched the video clip were significantly less anxious than men who did not watch it (mean STAI-State score IG 35.8±6.4 vs CG 38.2±7.6, p = 0.04). Surprisingly, infertility-specific distress was higher among women and men who watched the video clip (mean IDS scores of 25.8±4.9 and 22.6±5.0, respectively), as compared to women (p = 0.05) and men (p = 0.02) who did not watch the video clip (mean IDS score 24.3±4.6 and 20.8±4.7, respectively). All women and men of the intervention group, except one woman, would recommend the video clip to friends and family going through IVF. The intervention and control group did not differ significantly regarding clinical pregnancy rate (31/76 vs. 29/79, p = 0.60) or miscarriage rate (2/76 vs. 3/79, p = 0.68) 12 weeks after their first oocyte aspiration. Limitations, reasons for caution Patients nor assessors were blinded and there was no attention control group. Selection bias is plausible although the participation rate was 89%. Assessing infertility-specific distress the day after watching the video clip was not optimal, as priming couples to feel infertility-specific distress short term is less problematic than longer term. Wider implications of the findings Providing additional procedural information is interesting for clinics as patients recommended the video clip and as it decreased men’s anxiety. A follow-up study should examine whether the video clip’s priming effect on infertility-specific distress lasts longer than only the day after and whether the video clip affects IVF discontinuation. Trial registration number NCT03717805

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