Effects and safety of Ding Kun Dan on IVF/ICSI-ET outcomes in patients with predicted poor ovarian response:A multicenter randomized clinical trial

Objective:To evaluate whether Ding Kun Dan(DKD)can improve the vitro fertilization/intracytoplasmic sperm injection and embryo transfer(IVF/ICSI-ET)outcomes in patients with predicted poor ovarian response(POR)safely and effectively.Methods:Prospective,multicenter,randomized controlled trial;A total of 278 POR patients were randomized in DKD group or immediate treatment group.Both groups received IVF or ICSI as a standard treatment while in the DKD group,DKD was administrated for 3 months before the IVF/ICSI cycle.The primary outcome was the ongoing pregnancy rate.The secondary outcomes include clinical pregnancy rate,biochemical pregnancy rate,total gonadotropin(Gn)dosage and duration,estradiol(E2)and progesterone(P)levels on human chorionic gonadotropin(hCG)trigger day,cycle cancellation rate,number of oocytes retrieved,high-quality embryo rate and any adverse events.Results:Compared to the immediate IVF treatment group,oral administration of DKD for 3 months before IVF led to a significant increase in ongoing pregnancy rate(30.0%v.s.17.6%,P<0.05),biochemical pregnancy rate(39.2%vs.25.2%,P<0.05),clinical pregnancy rate(36.7%vs.22.7%,P<0.05)and high-quality embryo rate(40.8%vs.32.4%,P<0.05),and a significant decrease in Gn duration(P<0.05).However,no significant differences were found in total dosage of Gn,number of retrieved oocytes,cycle cancellation rate,E2 level and P level on hCG trigger days(P>0.05).No serious adverse events occurred during the intervention period in either group.Conclusion:DKD is a safe and effective intervention to improve the IVF/ICSI-ET outcomes in patients with POR.

尿源性卵泡刺激素用于促排卵治疗的临床疗效、安全性与经济性:基于102 061个体外受精周期的多中心回顾性队列研究

目的:探讨尿源性卵泡刺激素(uFSH)与重组卵泡刺激素(rFSH)在控制性促排卵中的有效性、安全性和费用差异。方法:本研究是一项回顾性队列研究。数据来自全国16家生殖中心,所收集周期的取卵时间为2015年5月1日至2018年6月30日,使用uFSH(uFSH组)或rFSH(rFSH组)作为起始促性腺激素(Gn)进行控制性促排卵,并使用体外受精(IVF)和(或)卵母细胞胞质内单精子注射进行受精的新鲜周期。由于同一患者可多次接受IVF周期治疗且在同一中心内进行的周期间不独立,故使用广义估计方程进行多因素分析,纳入调整的变量包括年龄、体质指数、抗苗勒管激素水平、不孕原因、促排卵方案、受精方式、移植胚胎数、Gn使用天数。结果:本研究共纳入102 061个新鲜周期进行分析。在有效性方面,当控制不平衡的基线特征后,与rFSH组相比,uFSH组的高获卵数(定义为获卵数>15个)率显著降低(促性腺激素释放激素激动剂方案: OR=0.642, P<0.01;促性腺激素释放激素拮抗剂方案: OR=0.556, P=0.001)。对比于rFSH组,无论激动剂方案还是拮抗剂方案,uFSH组每移植周期的临床妊娠率和每移植周期的活产率均显著增加( OR=1.179、1.169, P均<0.01)。在安全性方面,多因素分析结果显示,在激动剂方案中,与rFSH组相比,uFSH组中重度卵巢过度刺激综合征(OHSS)的发生率显著降低( OR=0.644, P=0.002);在所有方案中,uFSH组与rFSH组的异位妊娠率和多胎妊娠率差异均不显著( P=0.890、0.470)。在费用方面,与rFSH组相比,uFSH组的人均Gn总花费降低( P<0.01),rFSH组的预计成本为6 734元,uFSH组为3 880元。 结论:对于接受控制性促排卵的患者,uFSH相对于rFSH在安全性和经济性方面更有优势。