Effect of Acupuncture on IVF Pregnancy Outcomes for Women With Recurrent Implantation Failure: a Multi-center Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 771
- 试验地点
- 1
- 主要终点
- CPR
研究概览
简要总结
The randomized, placebo-controlled multicenter trial is conducted in five centers in China. After screening and obtaining the signed informed consent , the participants are randomly divided into three groups: acupuncture group (Acu.+IVF），sham acupuncture group（Sham Acu. +IVF），and the control group (only IVF).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To maintain blinding in patients, outcome assessors, and statisticians, the allocation sequence was concealed until the end of the study.
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Married women aged 25-40;
- •Repeated implantation failure for unknown reasons (experienced 2 or more embryo transfers of good-quality embryos without achieving clinical pregnancy);
- •Transplantable Day 3 high-quality frozen embryos or frozen blastocysts (≥3BB);
- •Estrogen and progesterone replacement therapy (HRT), endometrial thickness ≥7mm on the day of endometrial transformation.
排除标准
- •Patients who met any of the following conditions were not included.
- •Those who prepare for PGD;
- •Recipients of egg donors;
- •Chromosomal abnormalities in both or one of the couples (excluding chromosome polymorphism);
- •patients with implantation failure due to known embryonic factors;
- •Uterine lesions that may affect implantation (including uterine malformation, >4cm intramural fibroids，submucosal fibroids, adenomyosis, uterine tuberculosis, intrauterine adhesions, etc.
- •Repeated spontaneous abortion (2 or more fetal loss before 28 weeks of gestation);
- •Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
- •Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
- •Hydrosalpinx untreated;
- •BMI less than 18 or higher than 25kg/m2;
- •People with previous history of needle sickness;
- •Those who have previously participated in this study or received acupuncture treatment in the past 3 months.
- •Any situation that researchers consider inappropriate for participating in this study.
研究组 & 干预措施
Acupuncture group
Acupuncture + IVF.
干预措施: acupuncture and IVF (Device)
Sham acupuncture group
Sham acupuncture +IVF. We formulate and follow standardised step-by-step instructions and operations to use the same rituals in the acupuncture and sham acupuncture groups as far as possible.
干预措施: sham acupuncture and IVF (Device)
control group
only IVF
干预措施: control group (Other)
结局指标
主要结局
CPR
时间窗: 1 year
Clinical pregnancy rate
次要结局
- OPR(1 year)
- LBR(1 year)
- Biochemical indexes(before and after acupuncture treatment)
- Questionnaire score(before and after acupuncture treatment)
- β-HCG positive rate(1 year)
研究者
Cui Hong Zheng
associate professor
Huazhong University of Science and Technology