Corabian P, Hailey D
Alberta Heritage Foundation for Medical Research.
Int J Technol Assess Health Care. 1999 Winter;15(1):66-85. doi: 10.1017/s0266462399015172.
This paper examines the current status of in vitro fertilization and embryo transfer (IVF-ET) as a treatment for various types of infertility. We reviewed studies on the efficacy and safety of IVF-ET and intracytoplasmic sperm injection (ICSI) plus IVF-ET, compared with conventional treatment or no treatment for various infertility diagnoses. Material retrieved included English language publications between 1992 and January 1997 that reported the results of prospective controlled clinical trials, cohort studies, and retrospective comparative studies with large series, and reviews presenting risks, complications, and longer-term health consequences associated with IVF-ET and ICSI. No adequate prospective comparative studies of sufficient power on the use of IVF-ET for specific infertility diagnoses have been reported to date. Most of the published reports concerning results with IVF-ET as a treatment of infertility have been based upon small, uncontrolled studies, with various methodological weaknesses. Reported results are not directly comparable. There are few follow-up data on outcomes after pregnancy is established or on long-term health consequences of the use of IVF-ET on mothers and their babies. IVF-ET has diffused widely without comprehensive assessment of its efficacy and safety. The available evidence supports its use only for severe bilateral tubal occlusion. For other diagnoses of infertility the evidence is limited and does not establish whether IVF-ET is effective. Long-term, well-designed, prospective clinical trials are required to determine when and for what indications IVF-ET is effective and what its health effects are on both mothers and their babies.
本文探讨了体外受精-胚胎移植(IVF-ET)作为治疗各种类型不孕症的现状。我们回顾了关于IVF-ET以及卵胞浆内单精子注射(ICSI)联合IVF-ET的疗效和安全性的研究,并与针对各种不孕症诊断的传统治疗或不治疗进行了比较。检索到的资料包括1992年至1997年1月期间的英文出版物,这些出版物报告了前瞻性对照临床试验、队列研究以及具有大量样本的回顾性比较研究的结果,还包括介绍与IVF-ET和ICSI相关的风险、并发症及长期健康后果的综述。迄今为止,尚无关于将IVF-ET用于特定不孕症诊断的足够有力的前瞻性比较研究报告。大多数已发表的关于IVF-ET治疗不孕症结果的报告均基于小型、无对照的研究,存在各种方法学上的缺陷。报告的结果无法直接进行比较。关于妊娠确立后的结局以及IVF-ET对母亲及其婴儿的长期健康后果,几乎没有随访数据。IVF-ET在未对其疗效和安全性进行全面评估的情况下就已广泛传播。现有证据仅支持将其用于严重双侧输卵管阻塞。对于其他不孕症诊断,证据有限,无法确定IVF-ET是否有效。需要进行长期、精心设计的前瞻性临床试验,以确定IVF-ET何时以及针对何种适应症有效,以及其对母亲及其婴儿的健康影响如何。