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

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

Efficacy endpoint	CLD group	LD group	p
Efficacy endpoint	(n = 122)	(n = 125)	p
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

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 = 94; LD group, n = 91).
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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