A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates
A randomized controlled trial of the GnRH antagonist ganirelix in Chinese normal responders: high efficacy and pregnancy rates
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DOI：
10.3109/09513590.2012.665103
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发表时间：
2012-10-01
影响因子：
2
通讯作者：
Mannaerts, Bernadette
中科院分区：
文献类型：
--
作者：
Qiao, Jie;Lu, Guangxiu;Mannaerts, Bernadette
用于控制性卵巢刺激（COS）的促性腺激素释放激素（GnRH）拮抗剂最近才引入中国。 GnRH 拮抗剂加尼瑞克的疗效和安全性在一项多中心、对照、开放标签研究中进行了评估，其中中国女性被随机接受加尼瑞克 (n = 113) 或曲普瑞林长期 GnRH 激动剂方案 (n = 120)。主要终点是满足人绒毛膜促性腺激素标准（三个卵泡 = 17 毫米）所需的重组卵泡刺激素 (rFSH) 量。加尼瑞克 (1272 IU) 所需的 rFSH 量显着低于曲普瑞林 (1416 IU；P < 0.001)。每个开始周期的持续妊娠率为 39.8%（加尼瑞克）和 39.2%（曲普瑞林）。尽管两种治疗的耐受性良好，但加尼瑞克 (1.8%) 因卵巢过度刺激综合征 (OHSS) 风险而取消治疗的频率低于曲普瑞林 (7.5%) (P = 0.06)。与长 GnRH 激动剂方案相比，加尼瑞克方案所需的 rFSH 更少，报告的 OHSS 病例更少，妊娠率相似。
Gonadotropin-releasing hormone (GnRH) antagonists for controlled ovarian stimulation (COS) were only recently introduced into China. The efficacy and safety of the GnRH antagonist ganirelix was assessed in a multicenter, controlled, open-label study, in which Chinese women were randomized to either ganirelix (n = 113) or a long GnRH agonist protocol of triptorelin (n = 120). The primary end point was the amount of recombinant follicle-stimulating hormone (rFSH) required to meet the human chorionic gonadotropin criterion (three follicles = 17 mm). The amount of rFSH needed was significantly lower for ganirelix (1272 IU) vs. triptorelin (1416 IU; P < 0.001). Ongoing pregnancy rates per started cycle were 39.8% (ganirelix) and 39.2% (triptorelin). Although both treatments were well tolerated, cancellation due to risk of ovarian hyperstimulation syndrome (OHSS) was less frequent with ganirelix (1.8%) than triptorelin (7.5%) (P = 0.06). Less rFSH was needed in the ganirelix protocol than the long GnRH agonist protocol, with fewer reported cases of OHSS and similar pregnancy rates.