来曲唑片联合尿源性促卵泡生成素在高龄低反应患者高孕酮微刺激促排卵方案中的临床研究

Clinical trial of letrozole tablets combined with urogenic follicle-stimulating hormone in the treatment of elderly and poor ovarian response patients with high-progesterone ovarian stimulation protocol

目的比较尿源性促卵泡生成素(uFSH)联合来曲唑片与基因重组的促卵泡生成素(rFSH)在高龄低反应(POR)患者高孕酮微刺激促排卵方案(PPOS)中的临床疗效及安全性。方法回顾性分析接受体外受精-胚胎移植/卵胞浆内单精子注射(ICSI)助孕治疗的不孕症患者,按所用促排卵药物分为对照组和试验组。对照组给予rFSH 150~225 U·d^(-1),皮下注射,于月经第2天开始至扳机日+醋酸甲羟孕酮(MPA)4~6 mg,每天口服至取卵后;试验组给予来曲唑每天5 mg,于月经第2天开始,共用5 d+uFSH 150~225 U·d^(-1),肌内注射,根据B超监测卵泡情况用至扳机日+MPA 4~6 mg,每天口服至取卵术后。比较2组患者的促排卵时间、促性腺激素(Gn)用量、获卵数、优胚率、囊胚形成率、冻胚移植妊娠率,以及药物不良反应的发生情况。结果试验组筛选200例,剔除5例,最终195例纳入分析;对照组筛选190例,剔除11例,最终179例纳入分析。治疗后,试验组和对照组的促排卵时间分别为(9.91±2.33)和(8.61±2.24)d,Gn用量分别为(2361.04±1095.92)和(1832.28±763.51)U,第5天囊胚数分别为(1.24±1.88)和(0.53±1.13)个,差异均有统计学意义(均P<0.05)。在ICSI授精方式下,试验组和对照组的囊胚形成率分别为53.73%和27.27%,差异有统计学意义(P<0.05)。2组患者在获卵数、成熟卵、受精率、第3天胚胎数、临床妊娠率、流产率等方面比较,差异均无统计学意义(均P>0.05)。2组患者试验期间均无明显的药物不良反应。结论来曲唑联合uFSH促排卵与单纯应用rFSH在高龄POR患者PPOS方案中均能获得良好的临床结局,前者可提高ICSI周期的囊胚形成率。

Objective To compare the clinical efficacy and safety of urogenic follicle-stimulating hormone(uFSH)combined with letrozole and recombinant follicle-stimulating hormone(rFSH)in high-progesterone ovarian stimulation(PPOS)regimen for elderly people with poor ovarian response(POR).MethodsA retrospective analysis of infertile patients undergoing in vitro fertilization(IVF)/intracytoplasmic injection(ICSI)therapy was conducted and the patients were divided into control and treatment groups according to the drugs used for ovulation induction.In the control group,rFSH was given at 150-225 U daily from the second day of menstruation until the trigger day plus medroxyprogesterone acetate(MPA)4-6 mg per day until oocyte retrieval.In the treatment group,letrozole was started on the second day of menstruation at a daily dose of 5 mg for 5 days.At the same time,150-225 U of uFSH was given daily until the trigger day.MPA 4-6 mg per day by oral administration until oocyte retrieval.The ovulation induction time,gonadotropin(Gn)dosage,number of oocytes retrieved,high-quality embryo rate,blastocyst formation rate,frozen embryo transfer pregnancy rate,and adverse drug reactions were compared between the two groups.Results In the treatment group,200 cases were screened,5 cases were excluded,and 195 cases were finally included in the analysis.In the control group,190 cases were screened,11 cases were excluded,and 179 cases were finally included in the analysis.After treatment,the ovulation induction time of the treatment group and the control group were(9.91±2.33)and(8.61±2.24)d,and the dosages of Gn were(2361.04±1095.92)and(1832.28±763.51)U,and the number of blastocysts on day 5 were(1.24±1.88)and(0.53±1.13),respectively,and the differences were statistically significant(all P<0.05).In ICSI cycle,the blastocystization rates of the treatment group and the control group were 53.73%and 27.27%,with significant difference(P<0.05).There were no significant differences in the number of oocytes retrieved,metaphase I,fertilization rate,the number of embryos on the third day,clinical pregnancy rate,and abortion rate between the two groups(all P>0.05).There were no obvious adverse drug reactions in the two groups.Conclusion Both letrozole combined with uFSH and rFSH alone can achieve good clinical outcomes in PPOS protocol for elderly POR patients,and the former can improve the blastocyst formation rate of ICSI cycle.