Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients

Abstract

To determine whether a brief self-administered cognitive coping and relaxation intervention (CCRI) would lead to decreased treatment termination in in vitro fertilization (IVF) patients compared with routine care (RC). Randomized, controlled, prospective study. Private academically affiliated infertility center. One hundred sixty-six women about to begin their first IVF cycle. Randomization to the self-administered CCRI or RC control group and then observation for 12 months. Treatment discontinuation within 12 months (primary outcome), clinical pregnancy rate and psychological well-being (secondary outcomes). The 12-month pregnancy rate was similar for the RC and CCRI groups (odds ratio [OR] 1.02; 95% CI, 0.53-1.98). Of the patients who were not pregnant on the first cycle, 15 of 46 (15.2%) patients assigned to RC discontinued compared with 5 of 55 (5.5%) patients assigned to the CCRI (OR 3.11; 95% CI, 0.756-12.80). The CCRI group engaged in statistically significantly more positive reappraisal coping (OR 0.275; 95% CI, 0.16, 0.39) than the RC control group (OR 0.097; 95% CI, -0.03, .23). The CCRI group had an improved Fertility Quality of Life (FertiQoL CORE: OR 4.07; 95% CI, 2.07, 6.06; FertiQoL Emotional: OR 5.95; 95% CI, 2.89, 9.00) compared with the control group (Core OR: 0.67; 95% CI, -1.55, 2.89; Emotional: OR -0.02, 95% CI, -3.36, 3.32). The CCRI group reported less global anxiety (OR 0.275; 95% CI, 0.16, 0.39) than the control group (OR 0.471; 95% CI, -2.40, 3.34). The CCRI reported positive evaluations for the intervention (e.g., ease of use, helpfulness, perceived stress reduction). Use of the CCRI tool led to improved psychological status but not statistically significantly more treatment cycles or a higher pregnancy rate. NCT01318291.