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Table 3 Efficacy and safety in the Chinese population by AMH group

From: Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection

Variable

AMH < 15 pmol/L

AMH ≥ 15 pmol/L

Follitropin delta (n = 77)

Follitropin alfa (n = 86)

P-value

Follitropin delta (n = 301)

Follitropin alfa (n = 295)

P-value

Gonadotropin use

 Duration of stimulation (days)

8.8 ± 1.4

8.6 ± 1.6

0.309a

9.2 ± 1.9

8.9 ± 1.5

0.047a

 Total dose (μg)

105.8 ± 16.7

110.2 ± 33.5

0.568a

69.2 ± 19.2

110.4 ± 30.6

 < 0.001a

 Average daily dose (μg/day)

12.0 ± 0.0

12.6 ± 1.7

0.279a

7.5 ± 1.7

12.3 ± 1.6

 < 0.001a

Number of follicles at end of stimulation

 Total number of follicles

10.3 ± 4.3

9.6 ± 4.4

0.302a

13.4 ± 5.8

15.6 ± 6.4

 < 0.001a

 Follicles ≥ 12 mm

8.8 ± 4.0

8.1 ± 4.1

0.238a

11.2 ± 5.2

13.1 ± 5.6

 < 0.001a

 Follicles ≥ 17 mm

4.0 ± 1.4

3.8 ± 1.3

0.309a

4.3 ± 1.9

4.7 ± 2.1

0.119a

Endocrine profile at end of stimulation

 FSH (IU/l)

17.0

13.3

 < 0.001b

10.4

12.1

 < 0.001b

 LH (IU/l)

2.0

2.3

0.124b

1.6

1.8

0.036b

 Estradiol (pmol/l)

6898

6239

0.179b

7029

10,204

 < 0.001b

 Progesterone (nmol/l)

3.1

2.7

0.215b

2.2

3.2

 < 0.001b

 Progesterone > 3.18 nmol/L

42 (54.5%)

39 (45.9%)

0.345c

79 (26.6%)

151 (52.1%)

 < 0.001c

 Inhibin A (ng/l)

341.3

310.2

0.159b

366.6

500.8

 < 0.001b

 Inhibin B (ng/l)

654.3

658.0

0.788b

1153.0

1320.2

 < 0.001b

Cancellations

 Cycle cancellation

0 (0.0%)

1 (1.2%)

1.000c

12 (4.0%)

4 (1.4%)

0.073c

 Cycle or transfer cancellation

6 (7.8%)

5 (5.8%)

0.757c

50 (16.6%)

66 (22.4%)

0.079c

Oocytes and embryos

 Women with at least one oocyte retrieved

76 (98.7%)

85 (98.8%)

1.000c

288 (95.7%)

290 (98.3%)

0.092c

 Oocytes retrieved (n)

9.2 ± 4.9

7.7 ± 3.6

0.068a

10.5 ± 6.4

13.9 ± 7.8

 < 0.001b

 Fertilized oocytes (n)

6.0 ± 3.3

5.0 ± 2.9

0.057a

6.4 ± 4.5

8.5 ± 5.2

 < 0.001a

 Fertilization rated (%)

66.0 ± 21.6

66.3 ± 22.9

0.914a

62.5 ± 23.2

61.8 ± 21.1

0.280a

 Day 3 embryos (n)

6.9 ± 3.8

5.7 ± 3.0

0.070a

7.4 ± 4.9

9.7 ± 5.7

 < 0.001a

 Day 3 good-quality embryos (n)

3.6 ± 2.9

3.4 ± 2.3

0.800a

4.6 ± 3.9

5.9 ± 4.5

 < 0.001a

OHSS

 Any OHSS

4 (5.2%)

1 (1.2%)

0.190c

30 (10.0%)

35 (11.9%)

0.512c

 Early OHSS (any grade)e

3 (3.9%)

0 (0.0%)

0.103c

15 (5.0%)

28 (9.5%)

0.039c

 Late OHSS (any grade)f

1 (1.3%)

1 (1.2%)

1.000c

15 (5.0%)

7 (2.4%)

0.127c

 Preventive interventionsg for early OHSS

0 (0.0%)

1 (1.2%)

1.000c

6 (2.0%)

15 (5.1%)

0.047c

 Early OHSS and/or preventive interventions

3 (3.9%)

1 (1.2%)

0.345c

20 (6.6%)

41 (13.9%)

0.004c

  1. Note: Values are means, mean ± SD, or n (%), unless otherwise stated
  2. AMH Anti-Müllerian hormone, number of patients with observations, FSH Follicle-stimulating hormone, LH Luteinising hormone, OHSS Ovarian hyperstimulation syndrome, SD Standard deviation
  3. aWilcoxon test
  4. bMultiplicative ANCOVA with treatment as factor and the log transformed day 1 level as covariate
  5. cFishers exact test
  6. dIn women with at least one oocyte retrieved
  7. eOnset ≤ 9 days after triggering of final follicular maturation
  8. fOnset ≥ 10 days after triggering of final follicular maturation
  9. gPreventive interventions included cycle cancellation due to excessive ovarian response and triggering of final follicular maturation with GnRH agonist