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

Table 3 Primary and secondary efficacy endpoint results in the per-protocol population

Efficacy endpoint	CLD group	LD group	p
Efficacy endpoint	(n = 95)	(n = 94)	p
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

Data are n (%).
^aNumber of patients with follicles ≥17 mm in diameter by Day 35 of stimulation.
^bDue to inadequate response.
^cPregnancy rate calculated per patients who received hCG injections (CLD group, n = 84; LD group, n = 82).
p values show the difference between treatment groups, using the Chi-square test.
CLD = chronic low-dose; hCG = human chorionic gonadotrophin; LD = low-dose.

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