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比较人绝经期促性腺激素、高纯度人绝经期促性腺激素和卵泡刺激素阿尔法在卵胞浆内单精子注射周期中的应用。

A comparison of menotropin, highly-purified menotropin and follitropin alfa in cycles of intracytoplasmic sperm injection.

机构信息

ANDROFERT - Centro de Referência para Reprodução Masculina, 13075-460 Campinas, São Paulo, Brazil.

出版信息

Reprod Biol Endocrinol. 2009 Oct 14;7:111. doi: 10.1186/1477-7827-7-111.

DOI:10.1186/1477-7827-7-111
PMID:19828024
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2768716/
Abstract

BACKGROUND

Over the last several decades, as a result of an evolution in manufacturing processes, a marked development has been made in the field of gonadotropins for ovarian stimulation. Initially, therapeutic gonadotropins were produced from a simple process of urine extraction and purification; now they are produced via a complex system involving recombinant technology, which yields gonadotropins with high levels of purity, quality, and consistency.

METHODS

A retrospective analysis of 865 consecutive intracytoplasmic sperm injection (ICSI) cycles of controlled ovarian hyperstimulation (COH) compared the clinical efficacy of three gonadotropins (menotropin [hMG; n = 299], highly-purified hMG [HP-hMG; n = 330] and follitropin alfa [r-hFSH; n = 236]) for ovarian stimulation after pituitary down-regulation. The endpoints were live birth rates and total doses of gonadotropin per cycle and per pregnancy.

RESULTS

Laboratory and clinical protocols remained unchanged over time, except for the type of gonadotropin used, which was introduced sequentially (hMG, then HP-hMG, and finally r-hFSH). Live birth rates were not significantly different for hMG (24.4%), HP-hMG (32.4%) and r-hFSH (30.1%; p = 0.09) groups. Total dose of gonadotropin per cycle was significantly higher in the hMG (2685 +/- 720 IU) and HP-hMG (2903 +/- 867 IU) groups compared with the r-hFSH-group (2268 +/- 747 IU; p < 0.001). Total dose of gonadotropin required to achieve clinical pregnancy was 15.7% and 11.0% higher for the hMG and HP-hMG groups, respectively, compared with the r-hFSH group, and for live births, the differences observed were 45.3% and 19.8%, respectively.

CONCLUSION

Although similar live birth rates were achieved, markedly lower doses of r-hFSH were required compared with hMG or HP-hMG.

摘要

背景

在过去的几十年中,由于制造工艺的发展,促性腺激素在卵巢刺激方面取得了显著的进展。最初,治疗性促性腺激素是通过简单的尿液提取和纯化过程生产的;现在,它们是通过涉及重组技术的复杂系统生产的,该系统产生具有高纯度、质量和一致性的促性腺激素。

方法

对 865 例连续接受控制性卵巢超刺激(COH)的胞浆内单精子注射(ICSI)周期进行回顾性分析,比较了三种促性腺激素(人绝经促性腺激素[hMG;n=299]、高纯度 hMG[HP-hMG;n=330]和重组卵泡刺激素阿尔法[r-hFSH;n=236])用于垂体下调后的卵巢刺激的临床疗效。终点是活产率和每个周期及每个妊娠的促性腺激素总剂量。

结果

实验室和临床方案在时间上保持不变,除了使用的促性腺激素类型不同,它是按顺序引入的(hMG,然后是 HP-hMG,最后是 r-hFSH)。hMG(24.4%)、HP-hMG(32.4%)和 r-hFSH(30.1%;p=0.09)组的活产率无显著差异。每个周期的促性腺激素总剂量在 hMG(2685±720 IU)和 HP-hMG(2903±867 IU)组明显高于 r-hFSH 组(2268±747 IU;p<0.001)。hMG 和 HP-hMG 组达到临床妊娠所需的促性腺激素总剂量分别比 r-hFSH 组高 15.7%和 11.0%,而活产所需的剂量分别高 45.3%和 19.8%。

结论

尽管活产率相似,但 r-hFSH 的剂量明显低于 hMG 或 HP-hMG。

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Compositional analyses of a human menopausal gonadotrophin preparation extracted from urine (menotropin). Identification of some of its major impurities.从尿液中提取的人绝经期促性腺激素制剂(尿促性素)的成分分析。对其一些主要杂质的鉴定。
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