Table 2.
Transvaginal ultrasound results and Baseline Lab Measurements in female participants by treatment arm
| Clomiphene | Letrozole | Gonadotropin | All | |
|---|---|---|---|---|
| Left ovary not visualized | 4/300(1.3%) | 4/298(1.3%) | 2/301(0.7%) | 10/899(1.1%) |
| Right ovary not visualized | 3/300(1.0%) | 1/298(0.3%) | 3/301(1.0%) | 7/899(0.8%) |
| Neither ovary visualized | 2/300(0.7%) | 0/298(0.0%) | 0/301(0.0%) | 2/899(0.2%) |
| Morphology | ||||
| Left: Normal | 160/295(54.2%) | 147/294(50.0%) | 174/299(58.2%) | 481/888(54.2%) |
| >12 follicles < 10 mm | 116/295(39.3%) | 133/294(45.2%) | 104/299(34.8%) | 353/888(39.8%) |
| Hyperthecotic | 19/295(6.4%) | 14/294(4.8%) | 21/299(7.0%) | 54/888(6.1%) |
| Right: Normal | 142/297(47.8%) | 150/297(50.5%) | 154/298(51.7%) | 446/892(50.0%) |
| >12 follicles < 10 mm | 135/297(45.5%) | 133/297(44.8%) | 115/298(38.6%) | 383/892(42.9%) |
| Hyperthecotic | 20/297(6.7%) | 14/297(4.7%) | 29/298(9.7%) | 63/892(7.1%) |
| Both ovaries: Neither ovary | ||||
| >12 follicles less than 12 mm | 104/294(35.4%) | 106/293(36.2%) | 118/296(39.9%) | 328/883(37.1%) |
| >12 follicles less than 12 mm /normal combination |
93/294(31.6%) | 84/293(28.7%) | 90/296(30.4%) | 267/883(30.2%) |
| >12 follicles less than 10 mm bilaterally |
97/294(33.0%) | 103/293(35.2%) | 88/296(29.7%) | 288/883(32.6%) |
| Left ovarian volume(cm3) | ||||
| N | 294 | 294 | 297 | 885 |
| Mean(SD) | 8.7(11.0) | 8.8(7.8) | 7.6(5.0) | 8.4(8.3) |
| Right ovarian volume(cm3) | ||||
| N | 295 | 297 | 295 | 887 |
| Mean(SD) | 9.4(6.7) | 9.7(8.4) | 9.1(7.1) | 9.4(7.4) |
| Patients with at least one follicle/cyst>10 mm diameter |
126/296(42.6%) | 119/296(40.2%) | 122/300(40.7%) | 367/892(41.1%) |
| Size of largest follicle/cyst (cm3) | ||||
| N | 118 | 112 | 109 | 339 |
| Mean(SD) | 6.6(16.0) | 4.0(7.3) | 3.7(9.5) | 4.8(11.7) |
| Antral follicle count: right ovary | ||||
| <5 | 42/293(14.3%) | 38/294(12.9%) | 37/294(12.6%) | 117/881(13.3%) |
| 5–10 | 131/293(44.7%) | 136/294(46.3%) | 143/294(48.6%) | 410/881(46.5%) |
| 10–15 | 71/293(24.2%) | 68/294(23.1%) | 61/294(20.7%) | 200/881(22.7%) |
| >15 | 49/293(16.7%) | 52/294(17.7%) | 53/294(18.0%) | 154/881(17.5%) |
| Antral follicle count: left ovary | ||||
| <5 | 38/292(13.0%) | 37/291(12.7%) | 53/294(18.0%) | 128/877(14.6%) |
| 5–10 | 142/292(48.6%) | 132/291(45.4%) | 140/294(47.6%) | 414/877(47.2%) |
| 10–15 | 67/292(22.9%) | 68/291(23.4%) | 54/294(18.4%) | 189/877(21.6%) |
| >15 | 45/292(15.4%) | 54/291(18.6%) | 47/294(16.0%) | 146/877(16.6%) |
| Antral follicle count: both ovaries | ||||
| N | 291 | 289 | 290 | 870 |
| Mean(SD) | 20.3(11.3) | 21.2(11.2) | 20.6(12.6) | 20.7(11.7) |
| <5 | 4/291(1.4%) | 5/289(1.7%) | 2/290(0.7%) | 11/870(1.3%) |
| 5–10 | 43/291(14.8%) | 39/289(13.5%) | 50/290(17.2%) | 132/870(15.2%) |
| 10–15 | ||||
| >15 | 60/291(20.6%) | 55/289(19.0%) | 66/290(22.8%) | 181/870(20.8%) |
| Reproductive Hormones | 184/291(63.2%) | 190/289(65.7%) | 172/290 (59.3%) | 546/870 (62.8%) |
| Total Testosterone (ng/dL) | ||||
| N | 293 | 287 | 293 | 873 |
| Mean(SD) | 24.7(16.6) | 24.9(15.5) | 26.4(29.7) | 25.3(21.6) |
| <=50 | 284/293(96.9%) | 274/287(95.5%) | 281/293(95.9%) | 839/873(96.1%) |
| 50–100 | 8/293(2.7%) | 10/287(3.5%) | 11/293(3.8%) | 29/873(3.3%) |
| 100–150 | 0/293(0.0%) | 3/287(1.0%) | 0/293(0.0%) | 3/873(0.3%) |
| >150 | 1/293(0.3%) | 0/287(0.0%) | 1/293(0.3%) | 2/873(0.2%) |
| Calculated Free Androgen Index | ||||
| N | 292 | 285 | 292 | 869 |
| Mean(SD) | 2.4(9.1) | 1.9(2.0) | 2.0(2.2) | 2.1(5.5) |
| <=5 | 280/292(95.9%) | 269/285(94.4%) | 276/292(94.5%) | 825/869(94.9%) |
| 5–10 | 9/292(3.1%) | 13/285(4.6%) | 13/292(4.5%) | 35/869(4.0%) |
| 10–20 | 1/292(0.3%) | 3/285(1.1%) | 2/292(0.7%) | 6/869(0.7%) |
| >20 | 2/292(0.7%) | 0/285(0.0%) | 1/292(0.3%) | 3/869(0.3%) |
| SHBG (nmol/L) | ||||
| N | 294 | 285 | 292 | 871 |
| Mean(SD) | 59.3(29.0) | 60.0(28.2) | 58.4(27.0) | 59.2(28.1) |
| <=25 | 24/294(8.2%) | 22/285(7.7%) | 21/292(7.2%) | 67/871(7.7%) |
| 25–50 | 99/294(33.7%) | 95/285(33.3%) | 112/292(38.4%) | 306/871(35.1%) |
| 50–75 | 101/294(34.4%) | 92/285(32.3%) | 83/292(28.4%) | 276/871(31.7%) |
| >75 | 70/294(23.8%) | 76/285(26.7%) | 76/292(26.0%) | 222/871(25.5%) |
| DHEAS (ug/dL) | ||||
| N | 294 | 287 | 293 | 874 |
| Mean(SD) | 128.4(65.2) | 131.4(68.9) | 134.2(63.4) | 131.3(65.8) |
| Androstenedione (ng/mL) | ||||
| N | 292 | 284 | 289 | 865 |
| Mean(SD) | 2.4(1.0) | 2.4(1.0) | 2.4(1.0) | 2.4(1.0) |
| Estradiol (pg/mL) | ||||
| N | 295 | 287 | 293 | 875 |
| Mean(SD) | 32.4(21.5) | 32.7(28.0) | 33.7(40.4) | 32.9(30.9) |
| Progesterone (ng/mL) | ||||
| N | 294 | 286 | 293 | 873 |
| Mean(SD) | 0.8(0.3) | 0.8(0.5) | 0.8(0.8) | 0.8(0.6) |
| FSH(mIU/mL) | ||||
| N | 295 | 287 | 293 | 875 |
| Mean(SD) | 7.2(2.8) | 7.0(2.9) | 6.9(2.4) | 7.0(2.7) |
| LH (mIU/mL) | ||||
| N | 295 | 284 | 292 | 871 |
| Mean(SD) | 5.0(2.5) | 5.4(3.4) | 4.9(2.5) | 5.1(2.9) |
| TSH(uIU/mL) | ||||
| N | 295 | 285 | 292 | 872 |
| Mean(SD) | 2.0(1.0) | 1.8(1.0)* | 2.0(1.1) | 1.9(1.0) |
| AMH (ng/mL) | ||||
| N | 295 | 287 | 292 | 874 |
| Mean(SD) | 2.6(2.1) | 2.6(1.9) | 2.6(2.1) | 2.6(2.1) |
| Metabolic Hormones Fasting glucose (mg/dL) |
||||
| N | 295 | 287 | 293 | 875 |
| Mean(SD) | 85.9(11.6) | 85.4(11.9) | 84.2(12.2) | 85.2(11.9) |
| <=100 | 273/295(92.5%) | 267/287(93.0%) | 275/293(93.9%) | 815/875(93.1%) |
| 100–125 | 20/295(6.8%) | 19/287(6.6%) | 18/293(6.1%) | 57/875(6.5%) |
| >125 | 2/295(0.7%) | 1/287(0.3%) | 0/293(0.0%) | 3/875(0.3%) |
| Fasting insulin (uIU/mL) | ||||
| N | 295 | 286 | 293 | 874 |
| Mean(SD) | 11.1(18.6) | 9.4(15.5) | 8.7(11.3) | 9.7(15.5) |
| <=10 | 209/295(70.8%) | 217/286(75.9%) | 213/293(72.7%) | 639/874(73.1%) |
| 10–20 | 54/295(18.3%) | 43/286(15.0%) | 56/293(19.1%) | 153/874(17.5%) |
| 20–50 | 23/295(7.8%) | 20/286(7.0%) | 18/293(6.1%) | 61/874(7.0%) |
| >50 | 9/295(3.1%) | 6/286(2.1%) | 6/293(2.0%) | 21/874(2.4%) |
| HOMA-IR | ||||
| N | 295 | 286 | 293 | 874 |
| Mean(SD) | 2.57(4.3) | 2.0(3.7) | 1.9(2.7) | 2.1(3.6) |
| Proinsulin (pmol/L) | ||||
| N | 293 | 282 | 293 | 868 |
| Mean(SD) | 13.7(8.7) | 12.9(9.4) | 12.1(7.1) | 12.9(8.6) |
| hsCRP (mg/L) | ||||
| N | 295 | 284 | 293 | 872 |
| Mean(SD) | 3.4(5.5) | 3.4(5.1) | 3.2(4.1) | 3.3(4.9) |
| Total cholesterol(mg/dL) | ||||
| N | 284 | 277 | 283 | 844 |
| Mean(SD) | 170.3(29.0) | 169.0(33.0) | 168.3(32.5) | 169.2(31.5) |
| Triglycerides(mg/dL) | ||||
| N | 284 | 277 | 283 | 844 |
| Mean(SD) | 96.6(54.3) | 92.0(45.6) | 95.7(56.7) | 94.8(52.4) |
| HDL cholesterol(mg/dL) | ||||
| N | 284 | 277 | 283 | 844 |
| Mean(SD) | 46.3(11.4) | 45.5(11.0) | 45.9(11.0) | 45.9(11.1) |
| LDL cholesterol(mg/dL) | ||||
| N | 284 | 277 | 283 | 844 |
| Mean(SD) | 109.9(35.3) | 108.3(27.6) | 108.9(36.6) | 109.0(33.4) |
| >15 | 184/291(63.2%) | 190/289(65.7%) | 172/290(59.3%) | 546/870(62.8%) |
P-value between 0.05 and 0.1.