Mixed-methods pilot feasibility single-arm trial of Beyond Fertility: a brief face-to-face psychosocial intervention to promote patients’ adjustment to the end of unsuccessful fertility treatment

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BACKGROUND: Infertility is a major public health issue with a 17.5% estimated lifetime prevalence. Despite advances in assisted reproductive technology (ART), almost half of those seeking ART end all treatment cycles without a child. Around 93% of patients want to be prepared and supported when facing unsuccessful treatment. Healthcare professionals perceive a high demand for such support, yet evidence-based interventions remain limited. This mixed-methods study evaluated the acceptability and feasibility of implementing and evaluating Beyond Fertility: a brief psychosocial intervention to promote patients' adjustment to the end of unsuccessful fertility treatment. Results will inform the design of a definitive randomised controlled trial (RCT) of Beyond Fertility. METHODS: This is a prospective, mixed-methods, single-arm pilot study. The Beyond Fertility intervention offers preventive care (one individual/couple session before patients start their last treatment cycle) and early interventive care (one individual/couple and five group sessions if treatment is unsuccessful) to promote patients' emotional and social adjustment to the end of unsuccessful treatment. Beyond Fertility's development integrated feedback from patients and healthcare professionals. Adults scheduled to start their last NHS-reimbursed in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) cycle, including the last transfer with own or donated gametes/embryos or preimplantation genetic testing (PGT)-at a large NHS hospital in Portugal were consecutively recruited. Participants completed online questionnaires at baseline (T1, pre-intervention), post-individual/couple sessions (T2), and post-intervention (T3). A post-intervention focus group (T3) gathered feedback on the intervention and the study protocol. Participants also completed online open-ended feasibility questions after each intervention session. Feasibility outcomes focused on demand, acceptability, implementation, practicality, and promise of efficacy. Exploratory analysis of efficacy was change in quality of life (FertiQoL, T1-T3). RESULTS: Thirty-two participants consented to participate, completed T1, and were allocated to Beyond Fertility (62.1% acceptance rate). Participants reported that preventive care was acceptable, feasible, and beneficial. After a negative cycle outcome, 30.0% (n = 9) of participants ended treatment, and most (n = 21, 70.0%) continued. Of those who ended treatment, most (n = 6, 66.7%) accepted the interventive care, reporting it helped them accept their unmet desire for children and pursue alternative life goals. One-third (n = 3, 33.3%) received all sessions. Reasons for non-acceptance or withdrawal from the intervention in the immediate aftermath of treatment were the emotional burden of unsuccessful treatment (33.3%) and the sessions' group format (22.2%). Facilitators of session uptake were flexible online/in-person scheduling and delivery. Individual quality-of-life trajectories suggested a possible recovery after unsuccessful treatment. CONCLUSIONS: Beyond Fertility was seen as adequate and valued, and it showed promise in improving patients' quality of life after unsuccessful treatment. Before efficacy testing, feasibility issues require changes to Beyond Fertility's logic model, including activity design and revisions to its evaluation to target a larger, more representative sample of participants.

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