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Aim  Outside of Japan, recombinant‐human chorionic gonadotropin (r‐ hCG ) is widely used for the induction of final follicular maturation and early luteinization in women undergoing ovulation induction; whereas in Japan, urine‐derived  hCG  (u‐ hCG ) is predominantly used. The primary objective of this study was to demonstrate the non‐inferiority of r‐ hCG  to u‐ hCG  for ovulation induction, as assessed by the ovulation rate.    Methods  This was an open‐label, parallel‐group, randomized, multicenter, phase  III  trial in Japanese women with anovulation or oligo‐ovulation secondary to hypothalamic–pituitary dysfunction or polycystic ovary syndrome, undergoing ovulation induction with recombinant‐human follicle‐stimulating hormone. The women were randomized (2:1) to receive either a single 250 μg s.c. dose of r‐ hCG  or a single 5000  IU  i.m. dose of u‐ hCG  for ovulation triggering.    Results  Eighty‐one women were randomized to either r‐ hCG  (n=54) or u‐ hCG  (n=27). Ovulation occurred in 100% of the participants and treatment with r‐ hCG  was observed to be non‐inferior to u‐ hCG  for ovulation induction. Overall, the type and severity of adverse events were as expected for women receiving fertility treatment.    Conclusion  This study demonstrated that r‐ hCG  was non‐inferior to u‐ hCG  for inducing ovulation. Furthermore, r‐ hCG  demonstrated an expected safety profile, with no new safety concerns identified.

reproductive medicine and biology

Phase  III  trial comparing the efficacy and safety of recombinant‐ or urine‐derived human chorionic gonadotropin for ovulation triggering in Japanese women diagnosed with anovulation or oligo‐ovulation and undergoing ovulation induction with follitropin‐alfa