Borm G, Mannaerts B
Hum Reprod. 2000 Jul;15(7):1490-8. doi: 10.1093/humrep/15.7.1490.
A multicentre, open-label, randomized study of the gonadotrophin-releasing hormone (GnRH) antagonist ganirelix (Orgalutran((R))/Antagon((TM))) was performed in women undergoing ovarian stimulation with recombinant FSH (rFSH: Puregon((R))). The study was designed as a non-inferiority study using a long protocol of buserelin (intranasal) and rFSH as a reference treatment. A total of 730 subjects was randomized in a treatment ratio of 2:1 (ganirelix:buserelin) using an interactive voice response system which stratified for age, type of infertility and planned fertilization procedure [IVF or intracytoplasmic sperm injection (ICSI)]. The median duration of GnRH analogue treatment was 5 days in the ganirelix group and 26 days in the buserelin group, whereas the median total rFSH dose was 1500 IU and 1800 IU respectively. In addition, in the ganirelix group the mean duration of stimulation was 1 day shorter. During ganirelix treatment the incidence of LH rises (LH >/=10 IU/l) was 2.8% versus 1.3% during rFSH stimulation in the buserelin group. On the day of triggering ovulation by human chorionic gonadotrophin (HCG), the mean number of follicles >/=11 mm diameter was 10.7 and 11.8, and the median serum oestradiol concentrations were 1190 pg/ml and 1700 pg/ml in the ganirelix and buserelin groups respectively. The mean number of oocytes per retrieval was 9.1 and 10.4 respectively, whereas the mean number of good quality embryos was 3.3 and 3.5 respectively. The fertilization rate was equal in both groups (62.1%), and the same mean number of embryos (2.2) was replaced. The mean implantation rates were 15.7% and 21.8%, and the ongoing pregnancy rates per attempt were 20.3% and 25.7% in the ganirelix and buserelin groups respectively. Evaluation of all safety data indicated that the ganirelix regimen was safe and well tolerated. The overall incidence of ovarian hyperstimulation syndrome was 2.4% in the ganirelix group and 5.9% in the reference group. The results of this study support a safe, short and convenient treatment regimen of ganirelix, resulting in a good clinical outcome for patients undergoing ovarian stimulation for IVF or ICSI.
对接受重组促卵泡素（rFSH：果纳芬）卵巢刺激的女性进行了一项关于促性腺激素释放激素（GnRH）拮抗剂加尼瑞克（欧加农/安塔贡）的多中心、开放标签、随机研究。该研究设计为一项非劣效性研究，采用布舍瑞林（鼻内给药）长方案和rFSH作为对照治疗。使用交互式语音应答系统，按年龄、不孕类型和计划的受精程序（体外受精或卵胞浆内单精子注射）进行分层，将730名受试者按2:1的治疗比例（加尼瑞克：布舍瑞林）随机分组。加尼瑞克组GnRH类似物治疗的中位持续时间为5天，布舍瑞林组为26天，而rFSH的中位总剂量分别为1500 IU和1800 IU。此外，加尼瑞克组的平均刺激持续时间短1天。加尼瑞克治疗期间促黄体生成素升高（促黄体生成素≥10 IU/L）的发生率为2.8%，而布舍瑞林组rFSH刺激期间为1.3%。在用人绒毛膜促性腺激素（HCG）触发排卵当天，直径≥11 mm的卵泡平均数量在加尼瑞克组和布舍瑞林组分别为10.7和11.8，血清雌二醇中位浓度分别为1190 pg/ml和1700 pg/ml。每次取卵的平均卵母细胞数量分别为9.1和10.4，而优质胚胎的平均数量分别为3.3和3.5。两组的受精率相同（62.1%），移植的胚胎平均数量相同（2.2）。加尼瑞克组和布舍瑞林组的平均着床率分别为15.7%和21.8%，每次尝试的持续妊娠率分别为20.3%和25.7%。对所有安全性数据的评估表明，加尼瑞克方案安全且耐受性良好。加尼瑞克组卵巢过度刺激综合征的总体发生率为2.4%，对照组为5.9%。本研究结果支持加尼瑞克安全、简短且方便的治疗方案，该方案能为接受体外受精或卵胞浆内单精子注射卵巢刺激的患者带来良好的临床结局。
