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).