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在辅助生殖技术中,采用程序化灵活方案比较醋酸西曲瑞克和醋酸加尼瑞克预防过早促黄体生成素峰的前瞻性随机试验。

Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies.

作者信息

Wilcox John, Potter Daniel, Moore Marva, Ferrande Lee, Kelly Eduardo

机构信息

Huntington Reproductive Center, Pasadena, California, USA.

出版信息

Fertil Steril. 2005 Jul;84(1):108-17. doi: 10.1016/j.fertnstert.2005.03.016.

DOI:10.1016/j.fertnstert.2005.03.016
PMID:16009165
Abstract

OBJECTIVE

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).

DESIGN

Prospective, open-label, randomized, comparative study.

SETTING

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.

摘要

目的

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。

设计

前瞻性、开放标签、随机、对照研究。

地点

美国16个ART中心。

患者

185例接受ART的不孕患者。

干预措施

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)。

主要观察指标

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。

结果

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。

结论

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。

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