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在年龄<37 岁的女性中,与重组 FSH 相比,使用人 FSH 诱导排卵进行体外受精-胚胎移植(IVF-ET)后的妊娠结局:一项随机对照研究。

Pregnancy outcome following in vitro fertilization-embryo transfer (IVF-ET) in women aged < 37, undergoing ovulation induction with human FSH compared with recombinant FSH: a randomised controlled study.

机构信息

A.S.I.C., Rome, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2010 Feb;14(2):97-102.

Abstract

OBJECTIVE

To compare the pregnancy outcome in patients undergoing in vitro fertilization-embryo transfer (IVF-ET) cycles, using human derived follicle-stimulating hormone (FSH) or recombinant FSH for ovarian stimulation protocols.

DESIGN

Prospective, multi-centre, randomized controlled trial.

PATIENTS

115 infertile patients undergoing a first attempt of in vitro fertilization and embryo transfer were included in the study. The inclusion criteria were: female age < 37 years and use of GnRH agonist (GnRH-a) for pituitary downregulation.

INTERVENTIONS

Long Protocol-controlled ovarian stimulation with human derived FSH or recombinant FSH for IVF-ET.

MAIN OUTCOME MEASURES

Primary endpoints were implantation rate, clinical pregnancy rate and spontaneous abortion rate. Secondary end-points were total units of FSH injected, days of stimulation, peak estradiol levels at point of hCG administration, mean number of oocytes at pick-up, fertilization rate and cleavage rate.

RESULTS

No statistically significantly differences in pregnancy outcomes were found in the patients receiving hFSH in comparison to patients receiving rFSH.

CONCLUSIONS

This study did not demonstrate a difference between the use of h-FSH vs r-FSH for ovarian stimulation in terms of pregnancy outcome, in good prognosis patients undergoing their first IVF-ET procedure.

摘要

目的

比较使用人源性卵泡刺激素(FSH)或重组 FSH 进行卵巢刺激方案的体外受精-胚胎移植(IVF-ET)周期中患者的妊娠结局。

设计

前瞻性、多中心、随机对照试验。

患者

115 名接受首次体外受精和胚胎移植的不孕患者纳入研究。纳入标准为:女性年龄<37 岁,使用 GnRH 激动剂(GnRH-a)进行垂体降调节。

干预

使用人源性 FSH 或重组 FSH 进行长方案控制性卵巢刺激进行 IVF-ET。

主要观察指标

主要终点是着床率、临床妊娠率和自然流产率。次要终点是总 FSH 用量、刺激天数、HCG 给药时的雌二醇峰值、取卵时的平均卵母细胞数、受精率和卵裂率。

结果

接受 hFSH 治疗的患者与接受 rFSH 治疗的患者相比,妊娠结局无统计学显著差异。

结论

本研究未显示在进行首次 IVF-ET 手术的预后良好的患者中,使用 h-FSH 与 r-FSH 进行卵巢刺激在妊娠结局方面存在差异。

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