口服避孕药预处理对改良长方案体外受精/卵胞质内单精子显微注射活产率影响的一项倾向评分匹配研究

目的探讨口服避孕药(oral contraceptive,OC)预处理对改良长方案体外受精-胚胎移植(in vitro fertilization and embryo transfer,IVF-ET)/卵胞质内单精子显微注射(intracytoplasmic sperm injection,ICSI)妊娠结局的影响。方法回顾性分析了2012年1月至2017年12月期间于中国人民解放军陆军第七十三集团军医院生殖中心采用改良长方案13542个周期,根据降调节前是否采用OC预处理分为OC组(591例)和非OC组(12951例)。通过倾向评分匹配方法均衡两组间的变量后,比较两组的获卵数、成熟卵母细胞数、受精卵数、人绒毛膜促性腺激素(human chorionic gonadotropin,hCG)扳机日雌二醇水平、hCG扳机日内膜厚度、妊娠率、活产率等。结果匹配前,OC组hCG扳机日雌二醇水平3118.00(2529.00)ng/L]低于非OC组3422.00(2733.00)ng/L],差异有统计学意义(P=0.001),两组新鲜周期的获卵数、成熟卵母数、受精数、hCG扳机日内膜厚度、临床妊娠率、活产率差异均无统计学意义(P>0.05)。但通过多因素logistics回归分析校正混杂因素后,OC组相对非OC组是降低活产率的负面因素(临床妊娠率OR=0.83,95%CI=0.68~1.02;活产率OR=0.82,95%CI=0.68~0.99)。匹配后,OC组与非OC组的临床妊娠率及活产率(临床妊娠率OR=0.94,95%CI=0.75~1.14,P=0.59;活产率OR=0.91,95%CI=0.74~1.13,P=0.38)差异均无统计学意义。Post-hoc效能检验表明研究的样本量能够在效能≥80%的水平上检测到主要终点不小于3.7%的差异。结论OC预处理对改良长方案的助孕结局没有显著的影响。

A propensity score matching study of oral contraceptive pretreatment on the live birth rate of modified long down-regulation protocol in in vitro fertilization and embryo transfer and intracytoplasmic sperm injection cycles

Objective To investigate the effect of oral contraceptive pretreatment on pregnancy outcome of modified long down-regulation protocol in in vitro fertilization and embryo transfer and intracytoplasmic sperm injection cycles.Methods Totally 13542 cycles were retrospectively analyzed in Reproductive Medicine Center of the 73th Group Military Hospital of PLA from January 2012 to December 2017.According to whether use oral contraceptives(OC)before down-regulation,they were divided into OC group(591 cases)and non-OC group(12951 cases).After the variables between the two groups were balanced by the propensity score matching method,the number of oocytes obtained,number of mature oocytes,number of fertilized oocytes,number of high-quality embryos,estradiol level on human chorionic gonadotropin(hCG)trigger day,endometrial thickness on hCG trigger day,the clinical pregnancy rate and the live birth rate of the two groups were compared.Results Before matching,the estradiol level on hCG triger day in OC group3118.00(2529.00)ng/L]was lower than that in non-OC group3422.00(2733.00)ng/L],with statistically significant difference(P=0.001),there was no significant difference between OC group and non-OC group in the number of harvested oocytes and mature oocytes,fertilization number,number of viable embryos,endometrial thickness on hCG trigger day,the clinical pregnancy rate and the live birth rate.However,after adjusting for confounding factors through multi-factor logistics regression analysis,OC group was the negative factor to reduce the live birth rate compared with non-OC group(clinical pregnancy rate OR=0.83,95%CI=0.68-1.02;live birth rate OR=0.82,with 95%CI=0.88-0.99).After matching,the clinical pregnancy rate and the live birth rate of OC group and non-OC group had no statistically significant differences(clinical pregnancy rate OR=0.94,95%CI=0.75-1.14,P=0.59;live birth rate OR=0.91,95%CI=0.74-1.13,P=0.38).A post-hoc power caculation demonstrated that the study sample size yielded>80%power to detect a no less than 3.7%difference between groups in the primary outcome.Conclusion The pretreatment of oral contraceptives has no significant effect on the outcome of modified long down-regulation protocol.