Randomized, active-controlled, comparative phase 3 efficacy and safety equivalence trial of Ovaleap® (recombinant human follicle-stimulating hormone) in infertile women using assisted reproduction technology (ART)

Table 5 Pregnancy characteristics (ITT population)

	Ovaleap®	Gonal-f®	Odds Ratio (95 % CI)	P-value^*
Biochemical pregnancies
All patients, n/N (%)	58/153 (37.9)	60/146 (41.1)	0.88 (0.55–1.41)	0.606
Clinical pregnancy rates, n/N (%)
All patients	43/153 (28.1)	52/146 (35.6)	0.71 (0.43–1.16)	0.172
Patients with oocyte retrieval	43/152 (28.3)	52/143 (36.4)	0.70 (0.42–1.14)	0.150
Patients with embryo transfer	43/141 (30.5)	52/134 (38.8)	0.70 (0.42–1.15)	0.163
Ongoing pregnancy rates, n/N (%)
All patients	42/153 (27.5)	49/146 (33.6)	0.76 (0.46–1.25)	0.275
Patients with oocyte retrieval	42/152 (27.6)	49/143 (34.3)	0.75 (0.45–1.23)	0.251
Patients with embryo transfer	42/141 (29.8)	49/134 (36.6)	0.74 (0.45–1.24)	0.255
Take-home baby rates, n/N (%)^a
All patients	41/153 (26.8)	47/146 (32.2)	0.78 (0.47–1.29)	0.335
Patients with oocyte retrieval	41/152 (27.0)	47/143 (32.9)	0.77 (0.46–1.27)	0.310
Patients with embryo transfer	41/141 (29.1)	47/134 (35.1)	0.77 (0.46–1.28)	0.307

^*Calculated using a Mantel-Haenszel test, adjusting for the country factor
^aTake-home baby rate equals the percentage of patients with live births (from fresh or frozen cycles) divided by the number of randomized patients. All other outcomes reported in this table only include pregnancies resulting from fresh cycles

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