来曲唑联合尿源性FSH与单独使用尿源性FSH方案在夫精宫腔内人工授精中活产率的比较

Comparison of live birth rate between letrozole combined with urinary-derived FSH and urinary-derived FSH alone in intrauterine insemination with husband sperm

目的比较宫腔内人工授精(IUI)周期中单独使用尿源性人卵泡刺激素和来曲唑联合尿源性人卵泡刺激素两种方案的活产率。方法本研究为前瞻性随机对照的临床研究。入组人群随机分为来曲唑联合尿源性人卵泡刺激素组(LE+Gn组,n=150)和单独使用尿源性人卵泡刺激素组(Gn组,n=150)诱导排卵后行IUI助孕。主要分析指标为两组的活产率,次要分析指标包括诱导排卵过程参数、流产率、多胎妊娠率以及不良事件、周期取消、退出等。结果295对夫妻被纳入本项研究。LE+Gn组与Gn组的活产率(21.33%vs.22.07%)、多胎妊娠率(2.63%vs.2.86%)及流产率(15.79%vs.8.57%)差异均无统计学意义(P>0.05)。与Gn组相比,LE+Gn组扳机日雌二醇水平较低[(1065.45±1104.90)pmol/L vs.(1648.20±1162.92)pmol/L]、子宫内膜较薄[(9.23±2.06)mm vs.(9.64±1.86)mm]、扳机日募集到直径≥18 mm卵泡较多[(1.07±0.41)vs.(0.96±0.50)]、Gn用量较少[(396.86±184.80)U vs.(730.90±481.14)U]、使用Gn周期天数较短[(5.29±2.13)d vs.(9.03±3.91)d],差异均有统计学意义(P<0.05)。两组间新生儿出生体重、出生孕周差异均无统计学意义(P>0.05)。结论LE+Gn方案和单独Gn方案在IUI周期中均可以获得较为理想的活产率;LE+Gn方案在降低多卵泡发育及HCG日雌激素水平、减少Gn使用剂量和时间方面可能比单独Gn方案更有优势。

Objective:To compare the live birth rate(LBR)between letrozole combined with urinary-derived FSH(u-FSH)and u-FSH alone in intrauterine insemination(IUI)with husband sperm.Methods:This is a prospective randomized controlled trial.The participants were randomly assigned according to ovarian induction with letrozole in combination with u-FSH(LE+Gn group,n=150)or u-FSH alone(Gn group,n=145)before IUI.The primary outcome was LBR.The secondary outcome included parameters during ovulation induction,the abortion rate,multiple pregnancy rate,the incidence of adverse events,cycle cancellation rate and the dropout rate and so on.Results:A total of 295 couples were included in this study.There were no significant differences in the LBR(21.33%vs.22.07%),multiple pregnancy rate(2.63%vs.2.86%)and abortion rate(15.79%vs.8.57%)between the tow groups.Women in the LE+Gn group had lower estradiol levels[(1065.45±1104.90)pmol/L vs.(1648.20±1162.92)pmol/L,P<0.05],thinner endometrium[(9.23±2.06)mm vs.(9.64±1.86)mm,P<0.05]and more follicles greater than 18 mm in diameter[(1.07±0.41)vs.(0.96±0.50),P<0.05]on HCG day compared to those in the Gn group.Compared with the Gn group,the LE+Gn group had less Gn dosage[(396.86±184.80)U vs.(730.90±481.14)U,P<0.05]and shorter duration of Gn use[(5.29±2.13)d vs.(9.03±3.91)d,P<0.05].There were no significant differences in the birth weight,gestational age between the two groups(P>0.05).Conclusions:Both treatment groups can achieve ideal live birth rate in IUI cycles.The LE+Gn may have advantages over the Gn in reducing multiple follicle development and the estrogen level on HCG day,as well as reducing Gn dosage and duration of use.