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Table 3 Primary and secondary efficacy endpoint results in the per-protocol 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 = 95) (n = 94)
Mono-follicular development a 61 (64.2) 59 (62.8) 0.96
Bi-follicular development a 16 (16.8) 19 (20.2) 0.68
Multi-follicular development a 11 (11.6) 10 (10.6) 0.84
Cycle cancellation rate b 7 (7.4) 6 (6.4) 0.79
hCG injection rate 84 (88.4) 82 (87.2) 0.98
Clinical pregnancy rate c 17 (20.2) 17 (20.7) 0.37
  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 = 84; LD group, n = 82).
  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.