Wilcox John, Potter Daniel, Moore Marva, Ferrande Lee, Kelly Eduardo
Huntington Reproductive Center, Pasadena, California, USA.
Fertil Steril. 2005 Jul;84(1):108-17. doi: 10.1016/j.fertnstert.2005.03.016.
To compare the safety and efficacy of single-dose cetrorelix acetate (3 mg) and daily ganirelix acetate (0.25 mg) in the inhibition of premature LH surge in women undergoing cycle-programmed ovarian stimulation before Assisted Reproductive Technology (ART).
Prospective, open-label, randomized, comparative study.
Sixteen ART centers in the United States.
PATIENT(S): One hundred eighty-five infertile patients undergoing ART.
INTERVENTION(S): Single injection of cetrorelix (3 mg SC) or daily dose of ganirelix (0.25 mg SC) was administered when the lead follicle was > or =14 mm. Daily cetrorelix (0.25 mg) was administered if the criteria for hCG administration were not met 4 days after receiving 3 mg of cetrorelix.
MAIN OUTCOME MEASURE(S): Percentage of patients who did not have a premature LH surge, defined as LH <10 IU/L on the day of hCG administration. The IVF and embryo transfer (ET) outcomes were assessed.
RESULT(S): No patient in either treatment group had a premature LH surge. There were no statistically significant differences between treatments for any IVF/intracytoplasmic sperm injection (ICSI) or ET outcomes, including pregnancy rate (PR). However, cetrorelix required significantly fewer injections than ganirelix. Similar safety profiles were observed.
CONCLUSION(S): Cetrorelix and ganirelix effectively prevented LH surges in oral contraceptive (OC) pill-programmed, flexible protocols, with similar safety profiles and PRs; however, cetrorelix required significantly fewer injections, increasing patient convenience.
比较单剂量醋酸西曲瑞克(3毫克)和每日注射醋酸加尼瑞克(0.25毫克)在辅助生殖技术(ART)前进行周期程序化卵巢刺激的女性中抑制过早促黄体生成素(LH)峰的安全性和有效性。
前瞻性、开放标签、随机、对照研究。
美国16个ART中心。
185例接受ART的不孕患者。
当主导卵泡≥14毫米时,单次注射西曲瑞克(3毫克皮下注射)或每日注射加尼瑞克(0.25毫克皮下注射)。如果在接受3毫克西曲瑞克4天后未达到注射人绒毛膜促性腺激素(hCG)的标准,则每日注射西曲瑞克(0.25毫克)。
未出现过早LH峰的患者百分比,定义为hCG注射当天LH<10国际单位/升。评估体外受精(IVF)和胚胎移植(ET)结局。
两个治疗组均无患者出现过早LH峰。在任何IVF/卵胞浆内单精子注射(ICSI)或ET结局方面,包括妊娠率(PR),治疗组之间均无统计学显著差异。然而,西曲瑞克所需的注射次数明显少于加尼瑞克。观察到相似的安全性。
西曲瑞克和加尼瑞克在口服避孕药(OC)方案灵活的程序中均能有效预防LH峰,安全性和PR相似;然而,西曲瑞克所需的注射次数明显较少,提高了患者的便利性。