Peer-reviewed article
Corifollitropin alfa N02 versus recombinant FSH for ovarian stimulation: a phase 3 trial and safety study in Chinese women.
Tingting Li, Xiujuan Chen, Yingpu Sun, Lei Jin, Jianqiao Liu et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a clinical trial of fertility treatment drugs (corifollitropin alfa and recombinant FSH) for ovarian stimulation in adult women. It compares the efficacy and safety of two hormone protocols used in assisted reproduction. The study is not about child well-being, child health outcomes, or child development.
Key points
Limitations
This document does not address child well-being and is therefore outside the scope of research on children's survival, development, protection, or participation.
Abstract
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.