Objectives: To evaluate the efficacy and safety of Chinese medicine Jianpi Antai formula in infertile women undergoing in vitro fertilization-embryo transfer (IVF-ET).
Methods: A total of 300 infertile women who underwent 2 frozen embryo transfer procedures at the Department of Reproductive Medicine, Sir Run Run Shaw Hospital were included in the study. They were randomly divided into study group and the control group according to a random number table. The study group received routine medication plus the Jianpi Antai formula during the period of embryo transfer, while the control group received routine medication only. The general condition, embryo implantation rate, clinical pregnancy rate, live birth rate, and the blood routine and liver and kidney function were evaluated and compared between two groups.
Results: There were 277 cases who completed the study, including 134 in the study group and 143 in the control group. The embryo implantation rate (68.7% vs. 55.9%, P<0.05), the clinical pregnancy rate (56.7% vs. 44.8%, P<0.05) and the live birth rate (50.7% vs. 37.8%, P<0.05) in the study group were all higher than those in the control group. Subgroup analysis revealed that in patients of advanced age (≥35 years), the embryo implantation rate, clinical pregnancy rate, and live birth rate in the study group were all higher than those in the control group (all P<0.05). In patients with decreased ovarian reserve function (anti-Müllerian hormone <1.68 ng/mL), the embryo implantation rate, clinical pregnancy rate, and live birth rate in the study group were all higher than those in the control group (all P<0.05). During the follow-up period, there were no abnormalities in the basic vital signs of both groups, and no adverse events were reported.
Conclusions: Jianpi Antai formula can improve the embryo implantation rate in infertile women undergoing IVF-ET, reduce the embryo miscarriage rate, increase the live birth rate, improve the clinical outcomes, and has a high level of safety.
目的: 评价健脾安胎方在接受体外受精-胚胎移植（IVF-ET）患者中的有效性和安全性，扩大健脾安胎方的应用范围。方法: 研究共纳入浙江大学医学院附属邵逸夫医院生殖科行两枚冻优胚移植术后的患者300例，按照随机数字表法分为观察组和对照组，观察组移植期常规用药+健脾安胎方，对照组仅予移植期常规用药。评估两组一般情况、胚胎种植率、临床妊娠率、活产率及血常规、肝肾功能等安全性指标。结果: 277例病例（观察组134例，对照组143例）完成研究并纳入统计。其中观察组胚胎种植率为68.7%，明显高于对照组胚胎种植率55.9%（P<0.05）；观察组临床妊娠率为56.7%，明显高于对照组临床妊娠率44.8%（P<0.05）；观察组活产率为50.7%，明显高于对照组活产率37.8%（P<0.05）。亚组分析发现，高龄患者（≥35岁）中，观察组的胚胎种植率、临床妊娠率和活产率均高于对照组（均P<0.05）；卵巢储备功能减退患者（抗米勒管激素<1.68 ng/mL）中，观察组的胚胎种植率、临床妊娠率和活产率均高于对照组（均P<0.05）。研究随访周期内，两组基本生命体征均无异常；均无皮疹、腹泻等不良事件。结论: 健脾安胎方能提高接受IVF-ET移植患者的胚胎着床率，降低移植胚胎流产率，改善妊娠结局，且安全性高。.
Keywords: Clinical pregnancy rate; Embryo implantation rate; In vitro fertilization-embryo transfer; Jianpi Antai Formula; Live birth rate; Safety.