1.1 Research object
This study was a cross-sectional survey, using convenience sampling method, and selected infertile men who underwent IVF/ICSI-ET assisted pregnancy in Department of Assisted Reproductive Medicine, Obstetrics and Gynecology Hospital Affiliated to Tongji University from March 2023 to September 2023 as the study objects. Inclusion criteria: (1) Meet WHO diagnostic criteria for male infertility; (2) The male reproductive system and physical examination are normal, no medical history affecting sperm quality; (3) The male has not received treatment that affects sperm quality before semen examination; (4) Informed consent and voluntary participation in the researcher. Exclusion criteria: (1) Patients who received sperm donation, surgical sperm extraction or frozen sperm during this assisted pregnancy cycle; (2) Patients with serious chronic diseases, tumors and other diseases; (3) Patients with poor ovarian reserve in their spouses were excluded: basal follicle-stimulating hormone (FSH) ≥10mIU/mL or sinus follicle number (AFC) < 5; Patients with uterine malformation, endometriosis, recurrent transmission; (4) chromosomal or genetic abnormalities of both spouses, preimplantation genetic testing (PGT); (5) Patients who have not completed embryo transfer, such as no embryo transfer cycle, embryo saving, embryo cryopreservation; (6) Patients with incomplete clinical data and incomplete information.
Clinical experts demonstrated and screened the factors that may affect the outcome of assisted pregnancy, including a total of 35 risk factors. According to the sample size calculation formula [9], 5 to 10 patients are required for each risk factor, and considering the sample loss rate of 10% to 20%, the pre-survey of small samples in our hospital shows that infertile men account for about 20.77% (43/207) of the population receiving assisted reproduction. The sample size of this study was 35×5× (1+0.2) ÷20.77%≈1011, and 1037 cases were eventually included. This study strictly adhered to the indications and complied with all laws, regulations and ethical principles, and was approved by the Ethics Committee of Obstetrics and Gynecology Hospital Affiliated to Tongji University (Ethics number: KS2313).
1.2 Methods
1.2.1 Survey Tools
1.2.1.1 General demographic information
The questionnaire was designed by oneself, including age, BMI, occupational status, household registration type, education level, annual household income, whether smoking, drinking alcohol, drinking tea, drinking cola, drinking coffee, daily sleep time and daily exercise time.
1.2.1.2 Sperm quality and secretion data collection
The results of the last semen examination before IVF/ICSI-ET were collected. The researchers were instructed to abstain from sex for 2 to 7 days before the examination, and to use the uniform semen and secretion treatment and analysis method. Semen routine (semen volume, sperm concentration, total sperm motility, etc.), sperm morphology (normal morphology rate, head malformation rate, mixed malformation rate), sperm DNA fragment index (DFI), sperm survival rate, anti-sperm antibodies, secretions (mycoplasma, chlamydia) and other data were extracted from the hospital's HIS system.
1.2.1.3 Sex hormones
3mL fasting venous blood was collected, serum was isolated and obtained, and serum total testosterone level was determined by chemiluminescence method.
1.2.1.4 Self-Rating Depression Scale (SDS) and Self-Rating Anxiety Scale (SAS) [10,11]
According to the symptoms of the patients in the last week, the 20 points of the scale were summed up to get the total crude score, standard score = crude score ×1.25. According to the Chinese norm results, the SDS standard was divided into 53 points, 53 ~ 62 points were classified as mild depression, 63 ~ 72 points were classified as moderate depression, and > 72 points were classified as severe depression. The SAS standard score is 50 points, of which 50 ~ 59 is classified as mild anxiety, 60 ~ 69 is classified as moderate anxiety, and > 70 and above is severe anxiety.
1.2.1.5 the Chinese version of perceived stress scale (CPSS)[12]
This scale was developed by Cohen equals in 1983 and revised by Chinese scholar Yang Tingzhong equals in 2003. Cronbach's alpha was 0.780, indicating high structural validity. The scale has 14 items in 2 dimensions. The total score between 11 and 26 indicates low perceived stress level, 27 to 41 indicates moderate stress level, and > 42 indicates high level.
1.2.1.6 Athens insomnia scale (AIS)
The scale was designed by Dan Sendmark[13] in 1985 and consisted of 8 items, with a total score ranging from 0 to 24, 0 to 3 as no sleep disorder, 4 to 6 as suspicious insomnia, and a total score > 6 as insomnia. After good reliability and validity test and strong diagnostic ability, Athens Sleep scale has become an internationally recognized self-assessment scale of sleep quality [14].
1.2.1.7 Observational indicators of assisted pregnancy outcome
The clinical pregnancy was observed in uterine cavity by B-ultrasonography 28 days after ET transplantation.
1.2.2 Investigation methods
After obtaining the consent of the patients, the male specialist nurses conducted a cross-sectional survey on the patients who met the criteria for scheduling on the day of operation. Semen and blood data were extracted from the clinical electronic medical record system. The unified guidance was used to ask patients to fill in the questionnaire on the spot according to the actual situation and give them enough time and an independent environment. A total of 1078 questionnaires were sent out, and 1037 were effectively collected, with an effective questionnaire recovery rate of 96.19%.
1.2.3 Statistical Methods
SPSS26.0 software was used for data analysis of the results of the two groups. The measurement data were expressed as mean ± standard deviation (±S), and the t test of two independent samples was used between groups. Counting data is expressed as "n (%)" and x2 test is used between the two groups. With assisted pregnancy outcome as dependent variable and statistically significant variables in univariate analysis as independent variables, binary Logistic regression model and chance Chi Square automatic interaction detection (CHAID) classification decision tree model were established respectively. Among them, the classification decision tree based on CHAID algorithm adopts x2 test or likelihood ratio x2 test results to determine the best grouping variables and segmentation points of the decision tree, and finally forms a classification tree [15]. In order to prevent the phenomenon of "over-fitting", the pre-pruning technology was applied to control the full growth of the decision tree [16] : the maximum tree depth was 3, the minimum sample size of the parent node was 100, and the minimum sample size of the child node was 50. Receiver operating characteristic (ROC) curve was drawn according to the predicted results of the model, and the difference between the two models was analyzed and compared by the area under ROC curve (AUC), sensitivity and specificity. Test level α=0.05.