CREATING AFFILIATIONS, LEARNING, AND MINDFULNESS FOR IN VITRO FERTILIZATION PATIENTS (CALM IVF)

Abstract

Objective: To determine if a psychoeducational group (PG) model can improve quality of life (QoL) in patients undergoing IVF. Materials and Methods: Patients starting their first IVF cycle at our institution between 8/13/2019 - 12/31/2020 were recruited. Exclusions included previous IVF treatment, use of donor gametes/embryos, and non-English speakers. Enrolled participants completed baseline surveys (FertiQoL, PHQ-9, GAD-7, the 2-index Connor-Davidson Resilience scale, and an IVF knowledge survey). Participants were assigned to groups of 5-8 couples by projected oocyte retrieval date. Randomization to control (standard of care (SOC)) or intervention (CALM IVF + SOC) was done at the group level. CALM IVF participants attended 3 one-hour PG sessions prior to oocyte retrieval. 3 days after retrieval, all participants repeated surveys. Participants were followed for 3 months after retrieval to determine outcome and return to care. We estimated needing a sample size of 40 to show a 13.5 point difference in FertiQoL scores with 82.5% power and α=0.05. Analyses were performed using Student’s t-tests or Fischer’s exact tests as appropriate. Intent-to-treat analyses were performed for overall group differences as well as for differences in outcomes for those participating during the COVID-19 pandemic (after IVF clinical operations were paused on 3/16/20). Results: 76 couples enrolled. Due to drop-out, 20 females and 11 males participated in CALM IVF, and 20 females and 13 males in the control group. Those randomized to CALM IVF were more likely to experience a cancelled oocyte retrieval or poor embryo development in comparison to control (26% vs 13%). Males had significantly higher total QoL (6.68 [0.39 – 12.98], p=0.039), treatment QoL (8.26 [0.69 – 15.82], p=0.034), and resilience (1.13 [0.54 – 1.72], p=0.001) change in scores from pre-treatment to post-treatment after participating in CALM IVF versus control. Prior to COVID clinical pause, knowledge scores in the CALM IVF group significantly increased compared with control (13.19 [3.53 – 22.84], p=0.011). CALM IVF groups spanning 3/16/2020 and those recruited after had a significant improvement in the social subscale score (11.67 [-0.54 – 22.79], p=0.042 and 10.42 [1.79 – 19.04], p=0.023, respectively). Rates of ongoing pregnancy and return to care were not significantly different between groups. Conclusions: QoL and resilience are improved in males participating in CALM IVF during their first IVF cycle. Prior to COVID-19 shutdowns, CALM IVF improved IVF knowledge scores in participants. In participants who underwent treatment after COVID-19 shutdowns, CALM IVF improved social QoL scores. Impact Statement: Male partners of the IVF dyad may receive significant fertility related QoL and resilience benefits from a PG intervention. Female partners may experience improved social QoL with PG experiences, especially during a time of additional stressors and isolation.