Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, McGill University, Montreal, QC, Canada.
Int J Womens Health. 2011;3:243-55. doi: 10.2147/IJWH.S15002. Epub 2011 Aug 8.
Corifollitropin alfa is a synthetic recombinant follicle-stimulating hormone (rFSH) molecule containing a hybrid beta subunit, which provides a plasma half-life of ∼65 hours while maintaining its pharmocodynamic activity. A single injection of corifollitropin alfa can replace daily FSH injections for the first week of ovarian stimulation for in vitro fertilization. Stimulation can be continued with daily FSH injections if the need arises. To date, more than 2500 anticipated normoresponder women have participated in clinical trials with corifollitropin alfa. It is noteworthy that one-third of women did not require additional gonadotropin injections and reached human chorionic gonadotropin criterion on day 8. The optimal corifollitropin dose has been calculated to be 100 μg for women with a body weight ≤60 kg and 150 μg for women with a body weight >60 kg, respectively. Combination of corifollitropin with daily gonadotropin-releasing hormone antagonist injections starting on stimulation day 5 seems to yield similar or significantly higher numbers of oocytes and good quality embryos, as well as similar ongoing pregnancy rates compared with women stimulated with daily rFSH injections. Stimulation characteristics, embryology, and clinical outcomes seem consistent with repeated corifollitropin-stimulated assisted reproductive technologies cycles. Multiple pregnancy or ovarian hyperstimulation syndrome rates with corifollitropin were not increased over daily FSH regimen. The corifollitropin alfa molecule does not seem to be immunogenic and does not induce neutralizing antibody formation. Drug hypersensitivity and injection-site reactions are not increased. Incidence and nature of adverse events and serious adverse events are similar to daily FSH injections. Current trials do not provide information regarding use of corifollitropin alfa in anticipated hyper- and poor responders to gonadotropin stimulation. Although corifollitropin alfa is unlikely to be teratogenic, at the moment data on congenital malformations is missing.
科尔福利托林阿尔法是一种合成的重组促卵泡激素(rFSH)分子,含有杂交β亚基,提供约 65 小时的血浆半衰期,同时保持其药效活性。单次注射科尔福利托林阿尔法可以替代体外受精卵巢刺激的第一周的每日 FSH 注射。如果需要,可以继续每日 FSH 注射进行刺激。迄今为止,已有超过 2500 名预期的正常反应者参加了科尔福利托林阿尔法的临床试验。值得注意的是,三分之一的女性不需要额外的促性腺激素注射,并且在第 8 天达到人绒毛膜促性腺激素标准。对于体重≤60 公斤的女性,最佳科尔福利托林剂量计算为 100μg,对于体重>60 公斤的女性,最佳剂量为 150μg。从刺激日 5 开始,每天与促性腺激素释放激素拮抗剂联合使用科尔福利托林似乎可以产生相似或显著更高数量的卵母细胞和优质胚胎,以及与每日 rFSH 注射刺激的女性相似的持续妊娠率。刺激特征、胚胎学和临床结果似乎与重复科尔福利托林刺激的辅助生殖技术周期一致。与每日 FSH 方案相比,科尔福利托林的多胎妊娠或卵巢过度刺激综合征发生率并未增加。科尔福利托林阿尔法分子似乎没有免疫原性,不会诱导中和抗体形成。药物过敏和注射部位反应没有增加。不良事件和严重不良事件的发生率和性质与每日 FSH 注射相似。目前的试验没有提供关于科尔福利托林阿尔法在预期的高反应者和低反应者对促性腺激素刺激的使用信息。尽管科尔福利托林阿尔法不太可能致畸,但目前缺乏关于先天性畸形的数据。