Creating affiliations, learning, and mindfulness for in vitro fertilization patients (CALM IVF): a clinical trial

OBJECTIVE: Determine if group psychoeducational support can improve in vitro fertilization (IVF) patients’ quality of life (QoL). DESIGN: Randomized controlled trial (NCT04048772). SETTING: University-affiliated IVF clinic. PATIENT(S): Women (n = 76) and male partners undergoing initial autologous IVF cycle from August 2019, to December 2020. INTERVENTION(S): Couples were assigned to groups based on projected oocyte retrieval date. Groups were randomly assigned to the control or intervention arm. Clinic closures because of the COVID-19 pandemic delayed treatment for a portion of participants. Groups were conducted in person before and virtually during the pandemic. MAIN OUTCOME MEASURE(S): The primary outcome was a change in fertility quality of life (FertiQoL) from baseline to 3 days after retrieval. Secondary outcomes were changes in depression (Patient Health Questionnaire 9), anxiety (Generalized Anxiety Disorder 7), resilience (Connor-Davidson Resilience scale), IVF knowledge scores, and the likelihood of return to treatment. RESULT(S): Knowledge scores among women in Creating Affiliations, Learning, and Mindfulness (CALM) for IVF groups significantly increased compared with control (mean difference 13.19 [3.53 – 22.84]) before the pandemic. During the pandemic, women in CALM IVF had significant improvement in the social FertiQoL score compared with controls (10.42 [1.79 – 19.04]). Compared with controls, male CALM IVF participants had significantly greater improvement in total FertiQoL (mean difference 6.68 [0.39 – 12.98]), treatment FertiQoL (8.26 [0.69 – 15.82]), and resilience (Connor-Davidson 1.13 [0.54 – 1.72]). Immediate return to care did not significantly differ between arms. CONCLUSION(S): For women undergoing IVF, group psychoeducational programs can improve IVF knowledge and social QoL during a pandemic. Participation in a group psychoeducational program can improve QoL and resilience in IVF dyad male partners. CLINICAL TRIAL REGISTRATION NUMBER: Trial registration NCT04048772.