Alice D Domar1, Jill Gross2, Kristin Rooney2, Jacky Boivin3. 1. Domar Center for Mind/Body Health, Boston IVF, Harvard Medical School, Boston, Massachusetts. Electronic address: domar@domarcenter.com. 2. Domar Center for Mind/Body Health, Boston IVF, Harvard Medical School, Boston, Massachusetts. 3. Cardiff Fertility Studies Research Group, School of Psychology, Cardiff University, Wales, United Kingdom.
Abstract
OBJECTIVE: 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). DESIGN: Randomized, controlled, prospective study. SETTING:Private academically affiliated infertility center. PATIENT(S): One hundred sixty-six women about to begin their first IVF cycle. INTERVENTION(S): Randomization to the self-administered CCRI or RC control group and then observation for 12 months. MAIN OUTCOME MEASURE(S): Treatment discontinuation within 12 months (primary outcome), clinical pregnancy rate and psychological well-being (secondary outcomes). RESULT(S): 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). CONCLUSION(S): Use of the CCRI tool led to improved psychological status but not statistically significantly more treatment cycles or a higher pregnancy rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT01318291.
RCT Entities:
OBJECTIVE: 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). DESIGN: Randomized, controlled, prospective study. SETTING: Private academically affiliated infertility center. PATIENT(S): One hundred sixty-six women about to begin their first IVF cycle. INTERVENTION(S): Randomization to the self-administered CCRI or RC control group and then observation for 12 months. MAIN OUTCOME MEASURE(S): Treatment discontinuation within 12 months (primary outcome), clinical pregnancy rate and psychological well-being (secondary outcomes). RESULT(S): 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). CONCLUSION(S): Use of the CCRI tool led to improved psychological status but not statistically significantly more treatment cycles or a higher pregnancy rate. CLINICAL TRIAL REGISTRATION NUMBER: NCT01318291.
Authors: Nanette Santoro; Esther Eisenberg; J C Trussell; LaTasha B Craig; Clarisa Gracia; Hao Huang; Ruben Alvero; Peter Casson; Gregory Christman; Christos Coutifaris; Michael Diamond; Susan Jin; Richard S Legro; Randal D Robinson; William D Schlaff; Heping Zhang Journal: Hum Reprod Date: 2016-07-07 Impact factor: 6.918