Corifollitropin alfa N02 versus recombinant FSH for ovarian stimulation: a phase 3 trial and safety study in Chinese women.
RESEARCH QUESTION: What is the efficacy and safety of corifollitropin alfa N02, a long-acting FSH analogue, in comparison with daily recombinant FSH (rFSH) for ovarian stimulation in Chinese women? DESIGN: In this double-blind, multicentre trial (NCT06091436), 474 women aged 20-39 years with a normal ovarian reserve were randomized 1:1 to a single subcutaneous dose of corifollitropin alfa N02 (100/150 μg; n = 238) or daily rFSH (150/225 IU; n = 236) for the first week of stimulation, followed by individualized daily rFSH from day 8. The primary objective was non-inferiority in the number of oocytes retrieved (margin -3). RESULTS: The corifollitropin alfa N02 group demonstrated non-inferiority, with a mean of 12.1 oocytes retrieved versus 10.9 in the daily rFSH group (estimated difference 1.2, 95% CI 0.23-2.12). The clinical pregnancy rate was 46.3% in the corifollitropin alfa N02 group and 51.1% in the daily rFSH group, and the ongoing pregnancy rate was 38.8% and 44.3%, respectively. Safety profiles were similar: ovarian hyperstimulation syndrome occurred in 3.8% of women in the corifollitropin alfa N02 group and 2.5% of women in the daily rFSH group, and treatment-related adverse events occurred in 15.2% and 11.0% of women, respectively. Pooled data from phase 2 and 3 trials reported neonatal outcomes at 12 months, with a birth defect rate of 7.6% for the corifollitropin alfa N02 group and 12.0% the daily rFSH group. Anti-drug antibodies were detected in 3.0% of women in the corifollitropin alfa N02 group without clinical impact. CONCLUSIONS: A single dose of corifollitropin alfa N02 was non-inferior to daily rFSH in terms of oocyte yield, with similar safety, offering a simplified ovarian stimulation alternative for Chinese women with a normal ovarian reserve.
Tingting Li, Xiujuan Chen, Yingpu Sun et al.