A.S.I.C., Rome, Italy.
Eur Rev Med Pharmacol Sci. 2010 Feb;14(2):97-102.
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.
Prospective, multi-centre, randomized controlled trial.
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.
Long Protocol-controlled ovarian stimulation with human derived FSH or recombinant FSH for IVF-ET.
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.
No statistically significantly differences in pregnancy outcomes were found in the patients receiving hFSH in comparison to patients receiving rFSH.
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.
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。
前瞻性、多中心、随机对照试验。
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。
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。
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。
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。