Effect of Acupuncture on the Clinical Outcome of IVF-ET in Patients With Recurrent Implantation Failure: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
In order to explore the effect of acupuncture on the clinical outcome of IVF-ET in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. In the control group, those patients do not receive any treatments during embryo transfer cycle. Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.
详细描述
In the field of assisted reproduction techonology, there are still 10% of patients with recurrent implantation failure. In order to explore the effect of acupuncture on the clinical outcome of IVF-ET in patients with recurrent implantation failure, the patients divide into the experimental group or the control group. In the experimental group, those patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. In the control group, those patients do not receive any treatments during embryo transfer cycle. Both of two group patients are checked including endometrial receptivity index and fill in SAS anxiety scale form. Statistical analysis of the two groups of primary endpoint (clinical pregnancy rate) and secondary endpoint (embryo implantation rate, biochemical pregnancy rate, early pregnancy loss rate, ongoing pregnancy rate, live birth rate)are done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A: ≥ 3 times embryo transfer failures，and at least accumulated 4 high-quality embryos were transferred
- •B: Two times consecutive embryo transfers failures, at least accumulated 4 high-quality embryos were transferred
- •Undergo IVF / ICSI / PGT;
- •Transfer 1-2 D3 cleavage embryos or blastocysts in IVF / ICSI and transfer 1 blastocyst in PGT;
- •20-38 years old female
- •Sign the informed consent voluntarily.
排除标准
- •Contraindications for pregnancy or assisted reproductive technology;
- •Chromosome abnormality of husband or wife (except polymorphism);
- •Abnormal gene diseases;
- •Untreated of uterine diseases that affect the uterine cavity morphology (uterine malformation, submucous myoma, adenomyosis, endometriosis and endometriosis etc.);
- •AMH < 1.1ng/ml or AFC < 7;
- •The most thickness of endometrium is less than 7 millimeter;
- •Those who have more than 2 times clinical pregnancy abortion;
- •Patients with serious primary diseases including cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and mental diseases
- •The treatment (such as acupuncture and traditional Chinese Medicine) related to help pregnancy had been carried out in the last 3 months.
结局指标
主要结局
Clinical pregnancy rate
时间窗: 6 months
Clinical pregnancy will be defined as ultrasonographic evidence of an intrauterine sac with or without a fetal heart at the 6th gestational week.
次要结局
- embryo implantation rate(6 months)
- biochemical pregnancy rate(6 months)
- live birth rate(12 mongths)
- early pregnancy loss rate(6 months)
- ongoing pregnancy rate(6 months)