Materials and Methods
This cross-sectional study enrolled all the patients in our institution (Piazza Della Vittoria 14 Srl; Genoa; Italy) whose IVF treatments have been interrupted or postponed due to the COVID-19 pandemic. Patients were identified, and demographic data were prospectively collected using dedicated software (Gineko, Cosa Srl, Rome, Italy) between 1 April 2020 and 10 June 2020.
The local Ethical Committee approved the study protocol (402/2020 CER Liguria), and all research was performed following relevant guidelines and regulations. All the women gave their informed consent for the collection and use of their data for research purposes. The study was registered in ClinicalTrials.gov (NCT04400942).
An anonymous electronic survey on Google Forms web application (Mountain View, California, United States) was e-mailed to the eligible study patients. A reminder e-mail was sent every week until the end of the study period. The purpose of this survey was explained to all participants with a brief introduction. Participants were asked to sign a privacy policy consent at the beginning. Survey participation was voluntary, and no incentives were offered.
The survey was composed of two distinct sections: the first part assessed presence and severity of anxiety and depression using the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-9 (PHQ-9); the second part evaluated the perspective of patients about restarting IVF treatment, even changing referral ART center. Subjects with pre-existing psychiatric disorders diagnosed by using DSM-V were excluded from the sample (9).
The GAD-7 represents a validated item based on seven items referring to DSM-IV criteria for assessing anxiety. The whole scale score can range from 0 to 21, and cut-off scores for mild, moderate, and severe anxiety symptoms are 5, 10, and 15, respectively (10). The PHQ-9 is a validated item based on nine items referring to DSM-IV criteria for assessing depression. The whole scale score can range from 0 to 27, and cut-off scores for mild, moderate, moderately severe, severe depression symptoms are 5, 10, 15, and 20, respectively (11). For both questionnaires, response options are “not at all”, “several days”, “more than half the days”, and “nearly every day”, scored as 0, 1, 2, and 3, respectively.
After the closing date for questionnaire submissions, results were downloaded as a CSV (comma-separated values) file to be categorized via Excel (version 16.39; Microsoft Corporation, Redmond, USA). Statistical analysis was carried out using Statistics Package for Social Sciences (SPSS, version 24.0 Chicago, IL, USA). Results of the survey were reported according to the CHERRIES Guidelines (12).