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撤回:在辅助生殖周期中,人绝经期促性腺激素与重组卵泡刺激素用于卵巢刺激的比较。

WITHDRAWN: Human menopausal gonadotropin versus recombinant follicle stimulation hormone for ovarian stimulation in assisted reproductive cycles.

作者信息

Westergaard Lars W, Bossuyt Patrick Mm, Van der Veen Fulco, van Wely Madelon

机构信息

Department of Obstetrics and Gynecology, Odense University Hospital, Odense C, Denmark, DK5000.

出版信息

Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD003973. doi: 10.1002/14651858.CD003973.pub2.

DOI:10.1002/14651858.CD003973.pub2
PMID:21328264
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10680421/
Abstract

BACKGROUND

hMG and recombinant FSH, have both been used successfully for controlled ovarian hyperstimulation in in vitro fertilization and embryo transfer (IVF-ET).

OBJECTIVES

To compare the effectiveness of hMG with rFSH in ovarian stimulation protocols in IVF or ICSI treatment cycles.

SEARCH STRATEGY

We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched 3rd Jan 2002), PubMed, MEDLINE, Web of Science (all searched 1985 to May 15 2002), and reference lists of articles. We also contacted manufacturers and researchers in the field.

SELECTION CRITERIA

Randomised trials comparing hMG with rFSH for ovarian stimulation in IVF or ICSI treatment for treatment of infertility in normogonadotrophic women.

DATA COLLECTION AND ANALYSIS

The main outcome measure was ongoing pregnancy/live birth per woman.Secondary outcomes included total gonadotrophin dose used, cancellation, number of oocytes retrieved, implantation, clinical pregnancy per woman, multiple pregnancy, spontaneous abortion and ovarian hyperstimulation syndrome. Peto odds ratios (OR) for hMG relative to rFSH were calculated after testing for homogeneity of treatment effect across all trials. Analyses were performed separately for the three different GnRHa protocols used: (1) without GnRHa down-regulation, (2) with GnRHa down-regulation using a short protocol and (3) with GnRHa down-regulation using a long protocol.

MAIN RESULTS

Eight trials that met the inclusion criteria could be identified. One trial did not use down-regulation, one trial used a short protocol and six trials used a long down-regulation protocol. In the one trial with non-down-regulated women and in the one trial that used a short down-regulation protocol there was no evidence of a difference between hMG and rFSH in any clinical outcome. Data of four truly randomised trials in women down-regulated using a long protocol could be pooled. There was no evidence of a difference between hMG and rFSH in ongoing pregnancy/live birth per woman (OR 1.27; 95% CI 0.98 to 1.64). Furthermore there was no clear difference on any of the secondary outcomes, although the clinical pregnancy rate per woman was of borderline significance in favour of hMG (summary OR 1.28; 95% CI 1.00 to 1.64). The other secondary outcomes were comparable for both gonadotrophins.

AUTHORS' CONCLUSIONS: For all three GnRHa protocols analysed there is insufficient evidence of a difference between hMG and rFSH on ongoing pregnancy or live birth. More large randomised trials are needed to estimate the difference between hMG and rFSH more precisely. Such trials should preferably (1) use a consistent long GnRHa protocol and (2) use a fixed dose of gonadotrophin such to prevent potentially subjective decisions of the clinician in dosing and (3) take live birth as primary endpoint. At this moment in time however, in prescribing gonadotrophins for ovarian hyperstimulation in IVF one should use the least expensive medication.

摘要

背景

人绝经期促性腺激素(hMG)和重组促卵泡素(rFSH)均已成功用于体外受精和胚胎移植(IVF-ET)中的控制性卵巢过度刺激。

目的

比较hMG与rFSH在IVF或ICSI治疗周期的卵巢刺激方案中的有效性。

检索策略

我们检索了Cochrane月经失调与生育力低下研究组的试验注册库(检索时间为2002年1月3日)、PubMed、MEDLINE、科学引文索引(均检索1985年至2002年5月15日)以及文章的参考文献列表。我们还联系了该领域的制造商和研究人员。

选择标准

比较hMG与rFSH用于IVF或ICSI治疗中正常促性腺激素水平女性不孕症的卵巢刺激的随机试验。

数据收集与分析

主要结局指标是每位女性的持续妊娠/活产。次要结局包括使用的促性腺激素总剂量、取消治疗、获取的卵母细胞数量、着床、每位女性的临床妊娠、多胎妊娠、自然流产和卵巢过度刺激综合征。在对所有试验的治疗效果进行同质性检验后,计算hMG相对于rFSH的Peto比值比(OR)。对使用的三种不同促性腺激素释放激素激动剂(GnRHa)方案分别进行分析:(1)不使用GnRHa降调节,(2)使用短方案进行GnRHa降调节,(3)使用长方案进行GnRHa降调节。

主要结果

可识别出八项符合纳入标准的试验。一项试验未使用降调节,一项试验使用短方案,六项试验使用长降调节方案。在一项未进行降调节的女性试验和一项使用短降调节方案的试验中,没有证据表明hMG与rFSH在任何临床结局上存在差异。可以汇总四项使用长方案进行降调节的女性真正随机试验的数据。在每位女性的持续妊娠/活产方面,没有证据表明hMG与rFSH存在差异(OR 1.27;95%置信区间0.98至1.64)。此外,在任何次要结局上均无明显差异,尽管每位女性的临床妊娠率倾向于hMG,具有临界显著性(汇总OR 1.28;95%置信区间1.00至1.64)。两种促性腺激素的其他次要结局相当。

作者结论

对于所分析的所有三种GnRHa方案,没有足够证据表明hMG与rFSH在持续妊娠或活产方面存在差异。需要更多大型随机试验来更精确地估计hMG与rFSH之间的差异。此类试验最好(1)使用一致的长GnRHa方案;(2)使用固定剂量的促性腺激素,以防止临床医生在给药时做出潜在主观决策;(3)将活产作为主要终点。然而,目前在IVF中为卵巢过度刺激开具促性腺激素时,应使用最便宜的药物。

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