Table 1.
Baseline demographic and clinical characteristics of the study population across four cohorts.
| Characteristic | Overall (n=10447) |
Training cohort | Internal validation (n=1259) |
P | Testing cohort (n=1259) |
P | External validation (n=2058) |
P | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Non-live birth (n=3386) |
Live birth (n=2485) |
P | ||||||||
| Demographics | ||||||||||
| Female Age, years | 33 [30, 37] | 35 [31, 39] | 32 [30, 35] | <0.001 | 33 [30, 37] | 0.133 | 33 [30, 37] | 0.449 | 32 [29, 36] | <0.001 |
| Male Age, years | 35 [32, 39] | 36 [32, 40] | 34 [31, 37] | <0.001 | 35 [32, 39] | 0.824 | 35 [32, 39] | 0.851 | 35 [32, 38] | 0.040 |
| Female BMI | 21.63 [19.95, 23.56] | 21.77 [20.00, 23.88] | 21.63 [19.92, 23.63] | 0.066 | 21.58 [19.91, 23.62] | 0.600 | 21.63 [19.89, 23.50] | 0.182 | 21.44 [19.98, 23.05] | <0.001 |
| Female Weight | 54.36 [51.62, 57.48] | 54.64 [51.96, 57.62] | 54.50 [51.76, 57.60] | 0.242 | 54.54 [51.96, 57.48] | 0.980 | 54.48 [51.84, 57.42] | 0.365 | 53.45 [50.39, 57.00] | <0.001 |
| Infertility duration, years | 3 [2, 6] | 3 [2, 6] | 3 [2, 5] | 0.005 | 3 [2, 5] | 0.091 | 3 [2, 6] | 0.877 | 3 [2, 6] | 0.213 |
| Infertility type, n (%) | <0.001 | 0.588 | 0.393 | 0.045 | ||||||
| Primary infertility | 4340 (41.5) | 1297 (38.3) | 1128 (45.4) | 509 (40.4) | 503 (40.0) | 903 (43.9) | ||||
| Secondary infertility | 6107 (58.5) | 2089 (61.7) | 1357 (54.6) | 750 (59.6) | 756 (60.0) | 1155 (56.1) | ||||
| Infertility causes, n (%) | ||||||||||
| Tubal/peritoneal factor | 6349 (60.8) | 1977 (58.4) | 1518 (61.1) | 0.040 | 751 (59.7) | 0.962 | 766 (60.8) | 0.407 | 1337 (65.0) | <0.001 |
| Endometriosis | 1249 (12.0) | 411 (12.1) | 338 (13.6) | 0.105 | 150 (11.9) | 0.441 | 162 (12.9) | 0.953 | 188 (9.1) | <0.001 |
| Ovulatory disorder | 1386 (13.3) | 345 (10.2) | 373 (15.0) | <0.001 | 159 (12.6) | 0.731 | 145 (11.5) | 0.512 | 364 (17.7) | <0.001 |
| Advanced age/DOR | 2704 (25.9) | 1184 (35.0) | 432 (17.4) | <0.001 | 333 (26.4) | 0.458 | 313 (24.9) | 0.058 | 442 (21.5) | <0.001 |
| Unexplained | 1495 (14.3) | 487 (14.4) | 396 (15.9) | 0.108 | 181 (14.4) | 0.578 | 195 (15.5) | 0.719 | 236 (11.5) | <0.001 |
| Male Factor | 5068 (48.5) | 1701 (50.2) | 1241 (49.9) | 0.368 | 632 (50.2) | 0.890 | 620 (49.2) | 0.740 | 874 (42.5) | <0.001 |
| Baseline hormones | ||||||||||
| FSH, IU/L | 6.83 [5.70, 8.30] | 7.04 [5.89, 8.63] | 6.83 [5.76, 8.13] | <0.001 | 6.92 [5.78, 8.48] | 0.935 | 6.99 [5.92, 8.42] | 0.486 | 6.30 [5.06, 7.70] | <0.001 |
| LH, IU/L | 4.49 [3.21, 6.14] | 4.61 [3.31, 6.29] | 4.70 [3.36, 6.39] | 0.048 | 4.70 [3.39, 6.34] | 0.872 | 4.70 [3.45, 6.43] | 0.227 | 3.77 [2.68, 5.25] | <0.001 |
| FSH/LH | 1.56 [1.14, 2.15] | 1.59 [1.15, 2.21] | 1.48 [1.07, 2.02] | <0.001 | 1.53 [1.13, 2.12] | 0.933 | 1.53 [1.13, 2.12] | 0.698 | 1.66 [1.23, 2.28] | <0.001 |
| E2, pg/mL | 36.00 [27.00, 50.00] | 37.00 [27.00, 53.00] | 36.00 [27.00, 48.00] | 0.007 | 36.00 [25.81, 53.06] | 0.519 | 35.29 [26.00, 50.00] | 0.101 | 36.46 [30.00, 46.96] | 0.012 |
| PRL, ng/ml | 15.75 [11.23, 22.31] | 15.68 [11.04, 21.94] | 15.92 [11.42, 22.59] | 0.035 | 16.08 [11.54, 22.61] | 0.208 | 16.25 [11.32, 23.43] | 0.115 | 15.26 [11.04, 21.56] | 0.060 |
| T, ng/ml | 0.25 [0.16, 0.38] | 0.24 [0.14, 0.36] | 0.25 [0.16, 0.38] | 0.010 | 0.24 [0.15, 0.39] | 0.424 | 0.23 [0.15, 0.37] | 0.471 | 0.29 [0.19, 0.39] | <0.001 |
| AMH, ng/mL | 2.46 [1.39, 3.99] | 2.19 [1.18, 3.63] | 2.67 [1.58, 4.22] | <0.001 | 2.46 [1.35, 4.03] | 0.332 | 2.49 [1.49, 3.86] | 0.146 | 2.70 [1.57, 4.28] | <0.001 |
| AFC, n | 11 [7, 16] | 10 [6, 15] | 12 [8, 18] | <0.001 | 11 [7, 16] | 0.356 | 11 [7, 16] | 0.410 | 13 [8, 19] | <0.001 |
| Sperm parameters | ||||||||||
| Progressive motility, % | 46.00 [39.00, 52.96] | 45.80 [39.40, 52.20] | 46.00 [39.20, 52.40] | 0.817 | 46.00 [39.40, 52.50] | 0.650 | 45.80 [38.80, 52.38] | 0.449 | 47.00 [37.00, 56.00] | 0.007 |
| Concentration, 106/mL | 56.52 [42.84, 73.00] | 56.18 [43.40, 71.32] | 58.03 [44.78, 74.09] | <0.001 | 56.62 [43.82, 72.95] | 0.684 | 56.96 [44.19, 72.13] | 0.718 | 53.29 [35.92, 75.65] | <0.001 |
| Abnormal Sperm, % | 96.60 [95.40, 97.60] | 96.60 [95.60, 97.60] | 96.60 [95.40, 97.60] | 0.364 | 96.60 [95.40, 97.60] | 0.967 | 96.60 [95.59, 97.60] | 0.979 | 97.00 [95.20, 98.20] | <0.001 |
| DFI, % | 19.69 [16.34, 24.00] | 20.09 [16.61, 24.21] | 19.44 [16.07, 23.47] | <0.001 | 19.76 [16.53, 24.04] | 0.775 | 19.90 [16.62, 24.12] | 0.310 | 19.09 [15.18, 24.29] | <0.001 |
| HDS, % | 8.69 [7.21, 10.52] | 8.77 [7.29, 10.57] | 8.65 [7.19, 10.42] | 0.132 | 8.75 [7.36, 10.34] | 0.685 | 8.64 [7.28, 10.50] | 0.867 | 8.55 [6.83, 10.76] | 0.020 |
Data are presented as median [interquartile range] for continuous variables and n (%) for categorical variables. *P-value comparing training, internal, external validation, and testing cohorts; †P-value comparing live birth and non-live birth groups in the training cohort. *DOR, diminished ovarian reserve; BMI, body mass index; FSH, follicle-stimulating hormone; LH, luteinizing hormone; E2, estradiol; PRL, prolactin; AMH, anti-Müllerian hormone; AFC, antral follicle count; DFI, DNA fragmentation index. HDS, high DNA stainability.
The bold values in Table 1 indicate statistically significant differences (P < 0.05).