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Table 2 Primary and secondary efficacy endpoint results in the primary efficacy analysis population

From: Phase IV, open-label, randomized study of low-dose recombinant human follicle-stimulating hormone protocols for ovulation induction

Efficacy endpoint CLD group LD group p
(n = 122) (n = 125)
Mono-follicular development a 69 (56.6) 69 (55.2) 0.93
Bi-follicular development a 17 (13.9) 22 (17.6) 0.54
Multi-follicular development a 17 (13.9) 15 (12.0) 0.79
Cycle cancellation rate b 19 (15.6) 19 (15.2) 0.94
hCG injection rate 94 (77.1) 91 (72.8) 0.53
Clinical pregnancy rate c 19 (20.2) 18 (19.8) 0.94
  1. Data are n (%).
  2. aNumber of patients with follicles ≥17 mm in diameter by Day 35 of stimulation.
  3. bDue to inadequate response.
  4. cPregnancy rate calculated per patients who received hCG injections (CLD group, n = 94; LD group, n = 91).
  5. p values show the difference between treatment groups, using the Chi-square test.
  6. CLD = chronic low-dose; hCG = human chorionic gonadotrophin; LD = low-dose.