3.1. Study Design
This cross-sectional study enrolled 550 women referred to the IVF Department of Royan Institute. Following psychological evaluation, 502 women remained in the study. The study was conducted during the final stages of their IVF, ICSI, and IUI from February to May 2017. Inclusion criteria included married women without known psychological disorders [as determined by the General Health Questionnaire-28 (GHQ-28) and a psychological interview conducted by a psychologist)], aged 18 to 40 years, and literate in Persian. Exclusion criteria were incomplete questionnaires and incomplete embryo transfer or IUI procedures.
Participants met the researcher in the waiting room on their embryo transfer or IUI days. They were informed about the study objectives, provided informed consent, and assured of data confidentiality. Participants completed the GHQ-28. If their score was 23 or below, they underwent further evaluation for signs of depression and anxiety disorders based on DSM V by a professional psychologist before completing additional study questionnaires. Five weeks post-embryo transfer or IUI, clinical results were collected and provided to the researcher (
13).
Four questionnaires were utilized in the study. The GHQ-28 assessed general psychological health, while the type D Scale-14 (DS14) determined personality type (
14). The Morisky Medication Adherence Scale-8 (MMAS-8) evaluated medical adherence (
15). A researcher-developed questionnaire with 11 items gathered demographic information, including birth date, economic status, cause and duration of infertility, primary or secondary infertility, history of infertility treatment failure, and history of abortion.
The ART outcomes included chemical pregnancy, pregnancy failure, ectopic pregnancy, embryonic demise, and clinical pregnancy; the first four outcomes indicate non-pregnancy. Data were analyzed using SPSS version 22 (SPSS Inc, Chicago, IL, USA) with statistical tests such as one-way analysis of variance (ANOVA), chi-square, and Fisher exact tests. Data reporting adhered to the strengthening the reporting of observational studies in epidemiology (STROBE) guidelines (
16).
As previously mentioned, the GHQ-28 was utilized to assess patients’ general psychological health. It comprises 28 items evaluating four subscales: Somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression. Its internal consistency has been reported in the Iranian population (Cronbach α = 0.97) (
17,
18).
The DS14 is a tool consisting of 14 items designed to assess personality types, rated on a 5-point Likert scale. It includes two subscales: Negative affectivity and SI, each assessed using seven items. The score range for each subscale is 0 to 28, with a total score range of 0 to 56. Individuals scoring at least 10 on each subscale are classified as having a type D personality (
12). The reliability of each subscale has been acceptable in several studies, with Cronbach α values exceeding 0.8 in all (
8,
9,
19).
The MMAS-8 consists of eight items, seven with "yes" or "no" answers, and one requiring a response on a 5-point Likert scale. The total score range is 0 to 8. Individuals scoring 8 demonstrate high medical adherence, those scoring 6 to 8 exhibit moderate adherence, and scores below 6 indicate low adherence (
20,
21). The scale has been updated for diabetics in Iran, with internal consistency evaluated (Cronbach α = 0.72) (
22).