蒲公英提取物预处理对卵巢储备功能降低IVF失败患者助孕结局的影响

Effect of Dandelion Extract T-1 on diminished ovarian reserve patients with IVF failures

目的研究蒲公英提取物对卵巢储备功能降低IVF失败患者IVF结局的有效性及安全性。方法采用前瞻性非随机对照研究。符合卵巢储备功能降低的IVF失败史的女性分为研究组(即服用蒲公英提取物)及对照组(不服用蒲公英提取物),3个月后酌情进入促排周期,比较2组的基线数据及IVF结局相关指标。结果最终符合条件的进入统计的88人共计110个周期。研究组与对照组之间基线数据无明显差异。研究组与对照组相比,获卵数(4.21±2.76vs3.25±2.62,P=0.02)、成熟卵数(3.58±2.69vs2.54±2.04,P=0.03)、胚胎数(3.25±2.43vs2.05±1.72,P=0.03)、优质胚胎数(1.40±1.08 vs 0.51±0.65,P=0.00)、可利用胚胎数(2.21±1.35 vs 1.56±1.20,P=0.01)均显著增高;临床妊娠率及活产率有增高趋势(27.0%vs 16.3%;13.5%vs 8.2%),但无统计学差异。结论在IVF周期前口服蒲公英提取物进行预处理,可增加储备功能降低患者的成熟卵数及优质胚胎数。(临床试验注册号ChiCTR-OON-14005740)

Objective:To study the efficacy and safety of dandelion extract T-1(DE-T1)on IVF outcome in patients with IVF failure.Methods:A prospective,non-randomized,controlled trial was used.Criteria include anyone of those:basic FSH>10 IU/L,FSH/LH ratio increased>2,basic AMH<1.26μg/L,basic E2>80 pg/ml,basic AFC≤5).Patients received DE-T1 supplementation for 3 months(no other Chinese medicines were allowed to use)were the study group,while those not were the control group.The baseline data of the two groups and the IVF outcome related indicators were compared.Results:88 patients who met the criteria were enrolled in the study for a total of 110 cycles,with 53 in the study group and 57 in the control group.The average age of the entire study population was 35.67±3.79 years old,and the basic AFC was 4.77±2.80.There was no significant difference in baseline data between the study group and the control group.Between the study group and the control group,the number of retrieved eggs(4.21±2.76 vs 3.25±2.62,P<0.05),the number of MII stage eggs(3.58±2.69 vs2.54±2.04,P<0.05),embryos(3.25±2.43 vs 2.05±1.72,P<0.05),high-quality embryos(1.40±1.08 vs 0.51±0.65,P<0.01),and the number of available embryos(2.21±1.35 vs 1.56±1.20,P<0.01)were significantly difference.The clinical pregnancy rate and live birth rate were higher than the control group(27.0%vs 16.3%;13.5%vs 8.2%,P>0.05).Conclusion:Oral DE-T1 can be pre-treated before IVF cycle,which may increase the reserve ovary function and reduce the number of mature eggs and the number of high-quality embryos.It is necessary to study the clinical pregnancy rate and live birth rate in a large scale sample in the future.(ChiCTR-OON-14005740)