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重组人绒毛膜促性腺激素与尿源性人绒毛膜促性腺激素用于体外受精和卵胞浆内单精子注射周期中最终卵母细胞成熟触发的比较

Recombinant versus urinary human chorionic gonadotrophin for final oocyte maturation triggering in IVF and ICSI cycles.

作者信息

Youssef Mohamed Afm, Al-Inany Hesham G, Aboulghar Mohamed, Mansour Ragaa, Abou-Setta Ahmed M

机构信息

Obstetrics & Gynaecology, Faculty of Medicine - Cairo University, Cairo, Egypt and Center for Reproductive Medicine (CVV),University of Amsterdam, Netherlands, Cairo, Egypt.

出版信息

Cochrane Database Syst Rev. 2011 Apr 13(4):CD003719. doi: 10.1002/14651858.CD003719.pub3.

Abstract

BACKGROUND

For the last few decades urinary human chorionic gonadotrophin (hCG) has been used to induce final oocyte maturation triggering in in vitro fertilization (IVF) and intra-cytoplasmic sperm injection (ICSI) cycles. Recombinant technology has allowed the production of two drugs that can be used for the same purpose, to mimic the endogenous luteinizing hormone (LH) surge. This allows commercial production to be adjusted according to market requirements; the removal of all urinary contaminants; and the safe subcutaneous administration of a compound with less batch-to-batch variation. However, prior to a change in practice the effectiveness of the recombinant drugs should be known compared to the currently used urinary human chorionic gonadotrophin (uhCG).

OBJECTIVES

To assess the efficacy and safety of subcutaneous recombinant hCG (rhCG) and high dose recombinant LH (rLH) compared with intramuscular uhCG for inducing final oocyte maturation triggering in IVF and ICSI cycles.

SEARCH STRATEGY

We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (January 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010), MEDLINE (1966 to January 2010) and EMBASE (1980 to January 2010).

SELECTION CRITERIA

Two review authors independently scanned titles and abstracts and selected those that appeared relevant for collection of the full paper. Only truly randomised controlled trials comparing rhCG and rLH with urinary hCG for final oocyte maturation triggering in IVF and ICSI cycles for treatment of infertility in normo-gonadotropic women were included.

DATA COLLECTION AND ANALYSIS

Assessment for inclusion or exclusion, quality assessment and data extraction were performed independently by two authors. Discrepancies were discussed in the presence of a third author and consensus reached. Quality assessment included method of randomisation, allocation concealment, blinding of participants and assessors, reporting of a power calculation and intention-to-treat analysis.

MAIN RESULTS

Fourteen RCTs (n = 2306) were identified; 11 compared rhCG with uhCG and three compared rhLH with uhCG. There was no evidence of a statistically significant difference between rhCG and uhCG regarding the ongoing pregnancy or live birth rate (6 RCTs: OR 1.04, 95% CI 0.79 to 1.37; P = 0.83, I(2) = 0%). There was no significant difference in the incidence of ovarian hyperstimulation syndrome (OHSS) between rhCG and uhCG (3 RCTs: OR 1.5, 95% CI 0.37 to 4.1; P = 0.37, I(2) = 0%). There was no evidence of statistically significant difference between rhLH and uhCG regarding the ongoing pregnancy or live birth rate (OR 0.94, 95% CI 0.50 to 1.76) and incidence of OHSS (OR 0.82, 95% CI 0.39 to 1.69). These results leave open the possibility of strong differences in favour of either treatment for both ongoing pregnancy and OHSS.

AUTHORS' CONCLUSIONS: We conclude that there is no evidence of difference between rhCG or rhLH and uhCG in achieving final follicular maturation in IVF, with equivalent pregnancy rates and OHSS incidence. According to these findings uHCG is still the best choice for final oocyte maturation triggering in IVF and ICSI treatment cycles.

摘要

背景

在过去几十年里,尿源性人绒毛膜促性腺激素(hCG)一直被用于在体外受精(IVF)和卵胞浆内单精子注射(ICSI)周期中诱导最终卵母细胞成熟触发。重组技术已使得能够生产两种可用于相同目的的药物,以模拟内源性促黄体生成素(LH)峰。这使得商业生产能够根据市场需求进行调整;去除所有尿源性污染物;并安全地皮下注射一种批次间差异较小的化合物。然而,在改变实践之前,与目前使用的尿源性人绒毛膜促性腺激素(uhCG)相比,应了解重组药物的有效性。

目的

评估皮下注射重组hCG(rhCG)和高剂量重组LH(rLH)与肌肉注射uhCG相比,在IVF和ICSI周期中诱导最终卵母细胞成熟触发的疗效和安全性。

检索策略

我们检索了Cochrane月经紊乱与生育力低下组试验注册库(2010年1月)、Cochrane对照试验中央注册库(CENTRAL)(Cochrane图书馆2010年)、MEDLINE(1966年至2010年1月)和EMBASE(1980年至2010年1月)。

选择标准

两位综述作者独立浏览标题和摘要,并选择那些似乎相关的文献以收集全文。仅纳入了在IVF和ICSI周期中比较rhCG和rLH与尿源性hCG用于诱导最终卵母细胞成熟触发以治疗正常促性腺激素水平女性不孕症的真正随机对照试验。

数据收集与分析

两位作者独立进行纳入或排除评估、质量评估和数据提取。如有分歧,在第三位作者在场的情况下进行讨论并达成共识。质量评估包括随机化方法、分配隐藏、参与者和评估者的盲法、功效计算报告和意向性分析。

主要结果

共识别出14项随机对照试验(n = 2306);11项比较了rhCG与uhCG,3项比较了rhLH与uhCG。在持续妊娠率或活产率方面,没有证据表明rhCG与uhCG之间存在统计学显著差异(6项随机对照试验:OR 1.04,95%CI 0.79至1.37;P = 0.83,I² = 0%)。在卵巢过度刺激综合征(OHSS)发生率方面,rhCG与uhCG之间没有显著差异(3项随机对照试验:OR 1.5,95%CI 0.

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