Abstract Study question Do digital support tools for fertility patients improve psychological outcomes and pregnancy rates? Summary answer Overall, digital support tools for fertility patients do not improve depression, anxiety or Fertility Problem Index scores but have a beneficial effect on pregnancy rates. What is known already There are numerous mobile and web-based digital health tools in reproductive medicine, but the research evidence supporting the effect on clinical outcomes and to mitigate the psychological effects of infertility is sparse. If existing digital tools have demonstrated effectiveness in their stated aims of providing psychological support to patients during the arduous process of fertility treatment, it is vital to identify this so they can be implemented and further developed to tackle this important problem. In addition, if any digital tools have shown a positive impact on pregnancy rates, this would be of great interest to patients and clinicians alike. Study design, size, duration The study was prospectively registered (PROSPERO-CRD42020156441). An initial systematic review identified digital support tools and their salient features. This study presents meta-analysis of the data from RCT studies of digital support tools identified. Meta-analysis was performed of pregnancy rates, FPI (Fertility Problem Index), Depression and Anxiety scores between the digital support tool user and waiting list control groups. Studies were assessed for risk of bias (Cochrane risk of bias, robvis tool) and graded for quality. Participants/materials, setting, methods All studies were published after 2006. The RCT studies were conducted in the USA, Switzerland, Germany, UK, and The Netherlands. The total number of patients involved was 1268 (1059 women and 209 men). The average age of participants was 34.3 years. All studies reported psychological outcome scores. In 5 of the 10 studies identified pregnancy rates were reported. Meta-analysis was performed using the ‘meta’ package in R using random effects model to generate forest plots. Main results and the role of chance Overall, digital tools have a small positive impact on pregnancy rates, suggesting a beneficial effect for users of digital tools compared to non-user controls. Comparing digital support tools users with non-users, the clinical pregnancy rate (CPR) odds ratio (OR, with confidence interval) was 1.715 (1.042:2.82). The meta-analysis of the effect sizes of digital interventions on psychological outcomes, measured using validated measures of anxiety, depression, or the fertility specific FPI, identified no significant effects of digital interventions on patients’ psychological wellbeing. There was no significant standardized mean difference seen with the FPI analysis, SMD -0.10 (95% CI -0.26:0.05). As a variety of depression and anxiety outcome scales were used, there was insufficient comparable data to perform a quantitative meta-analysis for these outcomes and so this data is presented narratively. No convincing benefit of the digital tools to reduce symptoms of depression during fertility treatment is demonstrated in these studies. The impact of digital support tools on anxiety scores is somewhat mixed, with most studies demonstrating no significant difference in the anxiety scores between intervention and control group and a small number of statistically and clinically significant reductions in anxiety severity. Limitations, reasons for caution Meta-analysis was limited by the range of psychological outcome scales used. There were issues with deviation from intended interventions and missing outcome data. There is a risk the results of this meta-analysis were affected by publication bias, particularly the reporting of pregnancy rate, which was not included in all studies. Wider implications of the findings Establishing an agreed framework or core outcome set for evaluation of tools aiming to ameliorate the psychological distress associated with fertility treatments would be useful. Further research to explore the potential of digital support tools to impact pregnancy rates, particularly within fixed time frames/ treatment cycles, is warranted. Trial registration number N/A
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