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Table 2 Efficacy and safety in the Chinese population

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

Variable

Follitropin delta (n = 378)

Follitropin alfa (n = 381)

P-value

Gonadotropin use

 Duration of stimulation (days)

9.2 ± 1.8

8.8 ± 1.5

0.025a

 Total dose (μg)

76.7 ± 23.8

110.4 ± 31.2

 < 0.001a

 Average daily dose (μg/day)

8.5 ± 2.3

12.4 ± 1.6

 < 0.001a

Number of follicles at end of stimulation

 Total number of follicles

12.8 ± 5.6

14.2 ± 6.5

0.005a

 Follicles ≥ 12 mm

10.7 ± 5.0

12.0 ± 5.7

0.006a

 Follicles ≥ 17 mm

4.3 ± 1.8

4.5 ± 2.0

0.359a

Endocrine profile at end of stimulation

 FSH (IU/l)

11.5

12.4

 < 0.001b

 LH (IU/l)

1.7

1.9

0.011b

 Estradiol (pmol/l)

7001

9130

 < 0.001b

 Progesterone (nmol/l)

2.3

3.1

 < 0.001b

 Progesterone > 3.18 nmol/L

121 (32.4%)

190 (50.7%)

 < 0.001c

 Inhibin A (ng/l)

361.2

449.3

 < 0.001b

 Inhibin B (ng/l)

1022.6

1134.7

0.002b

Cancellations

 Cycle cancellation

12 (3.2%)

5 (1.3%)

0.085c

 Cycle or transfer cancellation

56 (14.8%)

71 (18.6%)

0.126c

Oocytes and embryos

 Women with at least one oocyte retrieved

364 (96.3%)

375 (98.4%)

0.068c

 Oocytes retrieved (n)

10.3 ± 6.2

12.5 ± 7.5

 < 0.001a

 Fertilized oocytes (n)

6.4 ± 4.2

7.7 ± 5.0

 < 0.001a

 Fertilization rated (%)

63.2 ± 22.8

62.8 ± 21.5

0.365a

 Day 3 embryos (n)

7.3 ± 4.7

8.8 ± 5.5

 < 0.001a

 Day 3 good-quality embryos (n)

4.4 ± 3.8

5.3 ± 4.2

0.002a

OHSS

 Any OHSS

34 (9.0%)

36 (9.4%)

0.764c

 Early OHSS (any grade)e

18 (4.8%)

28 (7.3%)

0.115c

 Late OHSS (any grade)f

16 (4.2%)

8 (2.1%)

0.098c

 Preventive interventionsg for early OHSS

6 (1.6%)

16 (4.2%)

0.025c

 Early OHSS and/or preventive interventions

23 (6.1%)

42 (11.0%)

0.011c

  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. aVan Elteren test adjusted for AMH group
  4. bMultiplicative ANCOVA with treatment and AMH group as factors and the log transformed day 1 level as covariate
  5. cLogistic regression model with treatment and AMH group as factors
  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