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目的:比较基因重组卵泡刺激素(r-FSH)及高纯度尿源性卵泡刺激素(HP-u FSH)对体外受精-胚胎移植(IVF-ET)妊娠结局的影响,结合临床表现从药学角度探讨和分析。方法:回顾分析具IVF/单精子卵细胞浆内显微注射授精(ICSI)指诊并首次接受IVF/ICSI助孕的不孕症患者235例,以给予的FSH药物种类不同分为2组:HP-u FSH组(n=135)和r-FSH组(n=100)。主要研究指标为出生率,次要研究指标为临床妊娠率,流产率及着床率。结果:HP-u FSH组外源性促性腺激素(Gn)总量和FSH量均多于r-FSH组(P<0.01),获卵数和可移植胚胎数较r-FSH组少(P<0.01),受精率较r-FSH组低(P<0.05)。两组平均Gn刺激天数,妊娠结局及中重度卵巢过度刺激综合征(OHSS)发生率均无统计学差异(P>0.05)。对患者年龄<35岁和≥35岁分别进行分组发现,年龄<35岁患者中的HP-u FSH组较r-FSH组平均年龄更大,不孕年限更长,基础窦卵泡数(AFC)更少(P<0.01),≥35岁患者中的HP-u FSH组与r-FSH组的基本特征(年龄,不孕年限,AFC)无统计学差异(P>0.05);无论年龄<35岁或年龄≥35岁,HP-u FSH组的Gn量和FSH量较r-FSH组均更大,获卵数及可移植胚胎数更少(P<0.01)。结论:在IVF/ICSI周期治疗中,国产HP-u FSH与r-FSH进行COS具有等同的IVF临床妊娠率及出生率。
OBJECTIVE: To compare the effect of recombinant human follicle stimulating hormone (r-FSH) and high-purity urine-derived follicle-stimulating hormone (HP-u FSH) on pregnancy outcome of IVF-ET in combination with clinical manifestations from a pharmacological point of view Discuss and analyze. Methods: A total of 235 infertility patients who underwent IVF / ICSI and were the first IVF / ICSI assisted pregnancy were retrospectively analyzed. Two groups were divided into two groups according to the types of FSH drugs administered: HP -u FSH group (n = 135) and r-FSH group (n = 100). The main research indicators for the birth rate, secondary research indicators for clinical pregnancy rate, abortion rate and implantation rate. Results: The total amount of gonadotropin (Gn) and FSH in HP-u FSH group were more than those in r-FSH group (P <0.01), and the number of oocytes and transfected embryos was less than that in r-FSH group <0.01). The fertilization rate was lower than that of r-FSH group (P <0.05). The average number of Gn stimulation days, pregnancy outcome and the incidence of moderate-severe ovarian hyperstimulation syndrome (OHSS) were not significantly different between the two groups (P> 0.05). The age of patients <35 years and> 35 years were grouped separately. The age of 35-year-old patients with HP-u FSH group than the r-FSH group average age, longer duration of infertility, basic atrial follicle number (AFC) (P <0.01). The basic characteristics (age, duration of infertility, AFC) of HP-u FSH group and r-FSH group were not statistically different (P> 0.05) The age or the age≥35 years old, the amount of Gn and FSH in HP-u FSH group were more than that in r-FSH group, and the number of oocytes and transfected embryos was less (P <0.01). CONCLUSIONS: In the IVF / ICSI cycle treatment, domestic HP-u FSH and r-FSH for COS have the same IVF clinical pregnancy rate and birth rate.