Xing Liwei, Xu Jinlong, Zhang Qiong, Li Li, Li Yunxiu, Zhuang Haina, Yuan Zhuojun, Zhao Rong, Ma Yanping
Yunnan University of Traditional Chinese Medicine.
Yunnan Second People's Hospital.
Medicine (Baltimore). 2020 Nov 20;99(47):e23234. doi: 10.1097/MD.0000000000023234.
Acupuncture and moxibustion has become a commonly used adjuvant treatment method to improve the success rate of in vitro fertilization-embryo transfer (IVF-ET). However, There is still insufficient evidence that acupuncture treatment can improve the local microenvironment of endometrium, the endometrial receptivity, and the pregnancy outcome of patients, which is worthy of further study.
METHOD/DESIGN: To investigate the effect of Stage by Stage Acupuncture and Moxibustion Therapy on endometrial receptivity and Pregnancy Outcome based on the theory of "Chong channel being sea of blood," we will conduct a multicenter randomized controlled trial. Inclusion criteria are as follows: infertile women under 45 years of age who received IVF-ET or Intracytoplasmic sperm injection cycles. The study will only be applied to women who have failed repeated implantation, that is, women who have failed 3 or more embryo transplants in the past (existing frozen embryos do not require the retrieval of eggs). Those who are not prepared to receive IVF-ET or are at risk of pregnancy, have a serious medical condition, or are egg donors will be excluded. Subjects will be randomly assigned to either the acupuncture group (IVF-ET plus stage-by-stage acupuncture and moxibustion therapy based on the "Chong channel being sea of blood" theory) or the control group (IVF-ET only). The trial required a total sample size of 246 women to compare endometrial receptivity between the 2 groups. The acupuncture group will receive acupuncture and moxibustion treatment 3 times a week starting from the third day of menstruation in the ovary stimulation cycle. One menstrual cycle was one course of treatment, and a total of 3 menstrual cycles were treated. The main outcome indicator was clinical pregnancy rate. Secondary outcome indicators were the three-dimensional volume blood flow parameters (vascularization index, flow index, and vascularization flow index) of the endometrium, endometrial thickness, endometrial volume, uterine artery PI, RI, and S/D during the "implantation window period" (20-24 days after menstruation in the ovary stimulation cycle).
This study will provide important evidence for the use of Stage by Stage Acupuncture and Moxibustion Therapy Based on the "Chong Channel Being Sea of Blood" Theory in IVF.
http://www.chictr.org.cn/edit.aspx?pid=28811&htm=4 ID: ChiCTR1800017191 (07/17/2018).
针灸已成为提高体外受精-胚胎移植（IVF-ET）成功率的常用辅助治疗方法。然而，目前仍缺乏足够证据表明针灸治疗能改善子宫内膜局部微环境、子宫内膜容受性及患者妊娠结局，值得进一步研究。
方法/设计：为基于“冲脉为血海”理论探讨分期针灸疗法对子宫内膜容受性及妊娠结局的影响，我们将开展一项多中心随机对照试验。纳入标准如下：年龄在45岁以下接受IVF-ET或卵胞浆内单精子注射周期的不孕女性。本研究仅适用于反复种植失败的女性，即既往有3次或以上胚胎移植失败的女性（现有冷冻胚胎则无需取卵）。不准备接受IVF-ET或有妊娠风险、患有严重内科疾病或为卵子捐赠者将被排除。受试者将被随机分为针灸组（IVF-ET加基于“冲脉为血海”理论的分期针灸疗法）或对照组（仅IVF-ET）。本试验共需246名女性样本量以比较两组间的子宫内膜容受性。针灸组将从促排卵周期月经第3天开始每周接受3次针灸治疗。1个月经周期为1个疗程，共治疗3个月经周期。主要结局指标为临床妊娠率。次要结局指标为“种植窗期”（促排卵周期月经第20 - 24天）子宫内膜的三维容积血流参数（血管化指数、血流指数和血管化血流指数）、子宫内膜厚度、子宫内膜容积、子宫动脉搏动指数（PI）、阻力指数（RI）和收缩期/舒张期比值（S/D）。
本研究将为基于“冲脉为血海”理论的分期针灸疗法应用于IVF提供重要证据。
http://www.chictr.org.cn/edit.aspx?pid=28811&htm=4 编号：ChiCTR1800017191（2018年7月17日）
