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Table 5 Pregnancy characteristics (ITT population)

From: 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)

  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
  1. *Calculated using a Mantel-Haenszel test, adjusting for the country factor
  2. 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