TCM Multi-channel Interventional Therapy for Assisting Reproduction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients with sucessful conception
研究概览
简要总结
Objective: To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.
Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.
详细描述
Objective
To evaluate the curative effect of TCM multi-channel interventional therapy on women with ART Failure; to compare the curative effect of the dual therapy and triple therapy on women with ART Failure; to choose the best TCM interventional therapeutic plan.
Methods: The cases with ART Failure from West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) meeting the inclusion criteria were randomly divided into three groups: the dual therapy group, the triple therapy group and the control group, compare the natural pregnancy number, the condition during the period of secondary IVF-ET and the improvement of the kidney deficiency, liver depression and blood stasis syndrome among those three groups.
The results will show the effect of TCM multi-channel interventional therapy for patients with ART failure
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
- None
入排标准
- 年龄范围
- 24 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •People aged 20 to 45
- •People with IVF - ET indications
- •People from Reproductive Center of West China second University Hospital of Sichuan University (West China Women's and Children's Hospital of Sichuan University) with long plan for IVE - ET Failure and then accept the secondary IVF-ET
- •People who conform to the standard of syndrome differentiation in TCM: kidney deficiency and liver depression and blood stasis
- •People with normal basic sex hormone levels
- •People who have recognized and voluntarily signed the informed consent. NOTICE: People who conform to the above 6 items can be included.
排除标准
- •People don't meet the inclusion criteria
- •The husband with less sperm and weak sperm seriously
- •People who have drug allergy or allergic constitution
- •People with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, etc. And mentally disordered patients
- •People who are complicated by acute infectious diseases and organic diseases
- •People have confirmed diagnosis malformed reproductive organs, reproductive system inflammation and tumors upon examination
- •People suffer from hereditary disease which is not suitable for fertility regulated in "maternal and infant health care law"
- •People who have the serious bad habits such as drug use
- •People who have contacted with birth defects rays, poison, drugs to a certain number and being in effect; NOTICE: People who conform to any of the terms above 9 will be ruled out.
研究组 & 干预措施
The control group
No Intervention
The dual therapy group
TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy.
干预措施: The dual therapy (Other)
The triple therapy group
TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM.
干预措施: The triple therapy (Other)
结局指标
主要结局
Proportion of patients with sucessful conception
时间窗: 10 weeks after embryo transplantation
次要结局
- Time to have successful conception(up to 26 weeks)
- Adverse events(0, 10, 26 weeks after randomization)
研究者
Huang Jinzhu
The evaluation of the curative effect onTCM joint treatment intervene in IVF-ET
Chengdu University of Traditional Chinese Medicine