Today is 2020-06-06

Acupuncture and Chinese Herbal Medicine to improve live birth rate of in vitro fertilization: a randomized controlled trial
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注册号:

Registration number:

ChiCTR2000032519 

最近更新日期:

Date of Last Refreshed on:

2020-05-01 

注册时间:

Date of Registration:

2020-05-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针药联合提高体外受精-胚胎移植患者活产率的随机对照试验 

Public title:

Acupuncture and Chinese Herbal Medicine to improve live birth rate of in vitro fertilization: a randomized controlled trial  

注册题目简写:

 

English Acronym:

IVFAct 

研究课题的正式科学名称:

针药联合提高体外受精-胚胎移植患者活产率的随机对照试验 

Scientific title:

Acupuncture and Chinese Herbal Medicine to improve live birth rate of in vitro fertilization: a randomized controlled trial  

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

ChiMCTR2000003267 

申请注册联系人:

秦慧超 

研究负责人:

吴效科 

Applicant:

Huichao Qin 

Study leader:

Xiaoke Wu 

申请注册联系人电话:

Applicant telephone:

+86 15567601455 

研究负责人电话:

Study leader's telephone:

+86 13796025599 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

422387215@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xiaokewu2002@vip.sina.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

黑龙江省哈尔滨市香坊区和平路26号 

研究负责人通讯地址:

黑龙江省哈尔滨市香坊区和平路26号 

Applicant address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China  

Study leader's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China  

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

黑龙江中医药大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital, Heilongjiang University of Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

HZYLLKY201901401 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

黑龙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethic Committee of the First Affiliated Hospital, Heilongjiang University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-25 

伦理委员会联系人:

赵楠 

Contact Name of the ethic committee:

Nan Zhao 

伦理委员会联系地址:

黑龙江省哈尔滨市香坊区和平路26号 

Contact Address of the ethic committee:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

黑龙江中医药大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital, Heilongjiang University of Chinese Medicine 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市香坊区和平路26号 

Primary sponsor's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

黑龙江

市(区县):

哈尔滨

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江中医药大学附属第一医院

具体地址:

香坊区和平路26号

Institution
hospital:

The First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Address:

26 Heping Road, Xiangfang District

经费或物资来源:

国家中医药管理局 

Source(s) of funding:

State Administration of Traditional Chinese Medicine of China  

研究疾病:

体外受精-胚胎移植 

Target disease:

in vitro fertilization - embryo transfer 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

明确在接受IVF的女性中,IVF前4周行针刺联合中药/中药安慰剂治疗,对比对照针刺联合中药/中药安慰剂治疗提高活产率的有效性问题。 

Objectives of Study:

To determine the efficacy of acupuncture with CHM or placebo CHM given 4 weeks prior to IVF compared with control acupuncture with CHM or placebo CHM on live birth in women undergoing IVF. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 女性患者≥20岁至≤40岁; 2. 具备IVF适应症; 3. 女性患者不孕时间>1 年; 4. 第3-5天进行鲜胚移植的IVF患者。 

Inclusion criteria

1. Women >= 20 to <=40 years of age; 2. Indications for IVF; 3. Duration of infertility >1 year; 4. Undergoing IVF with an intention of fresh ET on day 3 or 5. 

排除标准:

1.只计划移植冻胚; 2.胚胎植入前遗传学检查; 3.复发性流产史(定义为连续3次流产); 4.IVF前3个月内进行过中药或针刺治疗不孕; 5.肝肾功能异常。 

Exclusion criteria:

1. Women with an intention to replace frozen embryos only. 2. Preimplantation genetic testing. 3. History of recurrent miscarriages defined as having three consecutive miscarriages. 4. Having acupuncture or CHM for infertility within 3 months prior the IVF. 5. Women with abnormal liver or renal function tests. 

研究实施时间:

Study execute time:

From2020-10-01To 2022-12-31 

干预措施:

Interventions:

组别:

A

样本量:

682

Group:

A

Sample size:

干预措施:

针刺联合中药

干预措施代码:

Intervention:

acupuncture and CHM

Intervention code:

组别:

B

样本量:

682

Group:

B

Sample size:

干预措施:

针刺联合中药安慰剂

干预措施代码:

Intervention:

acupuncture and placebo CHM

Intervention code:

组别:

C

样本量:

682

Group:

C

Sample size:

干预措施:

对照针刺联合中药

干预措施代码:

Intervention:

control acupuncture and CHM

Intervention code:

组别:

D

样本量:

682

Group:

D

Sample size:

干预措施:

对照针刺联合中药安慰剂

干预措施代码:

Intervention:

control acupuncture and placebo CHM

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Heilongjiang 

City:

Harbin 

单位(医院):

黑龙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

大连 

Country:

China 

Province:

Liaoning 

City:

Dalian 

单位(医院):

大连妇女儿童医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Dalian Municipal Women and Children's Medical Center  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属盛京医院 

单位级别:

三级甲等 

Institution
hospital:

Shengjing Hospital of China Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

河南 

市(区县):

郑州 

Country:

China 

Province:

Henan 

City:

Zhengzhou 

单位(医院):

郑州大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital ofZhengzhou University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽医科大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Anhui Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

徐州 

Country:

China 

Province:

Jiangsu 

City:

Xuzhou 

单位(医院):

徐州市中心医院 

单位级别:

三级甲等 

Institution
hospital:

Xuzhou Central Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

淮安 

Country:

China 

Province:

Jiangsu 

City:

Huaian 

单位(医院):

江苏省淮安市妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Huaian Maternal and Child Health Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江西 

市(区县):

南昌 

Country:

China 

Province:

Jiangxi 

City:

Nanchang 

单位(医院):

江西省妇幼保健院 

单位级别:

三级甲等 

Institution
hospital:

Jiangxi Maternal and Child Health Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

兰州大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Hospital of Lanzhou University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

陕西 

市(区县):

西安 

Country:

China 

Province:

Shanxi 

City:

Xi'an 

单位(医院):

西北妇女儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Xibei Women and Children's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

香港 

市(区县):

 

Country:

China 

Province:

Hongkong 

City:

 

单位(医院):

香港中文大学威尔斯亲王医院 

单位级别:

三级甲等 

Institution
hospital:

The Chinese University of Hong Kong  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

活产

指标类型:

主要指标 

Outcome:

Live birth

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胚胎质量

指标类型:

次要指标 

Outcome:

Embryo quality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

流产率

指标类型:

次要指标 

Outcome:

Miscarriage rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

植入率

指标类型:

次要指标 

Outcome:

Implantation rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清hCG阳性(ET后2周)

指标类型:

次要指标 

Outcome:

Positive serum hCG level (2 weeks after ET)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

持续妊娠率(≥8周)

指标类型:

次要指标 

Outcome:

Ongoing pregnancy rate (≥8 weeks)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多胎妊娠率

指标类型:

次要指标 

Outcome:

Multiple pregnancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

异位妊娠率

指标类型:

次要指标 

Outcome:

Ectopic pregnancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

随机化后6个月内的累计活产率

指标类型:

次要指标 

Outcome:

Cumulative live birth rate within 6 months after randomization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

压力、焦虑和HRQoL指标的变化

指标类型:

次要指标 

Outcome:

Changes in markers of stress, anxiety and HRQoL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者在干预结束时测量针灸接受度

指标类型:

次要指标 

Outcome:

Patient acceptability of acupuncture to be measured at the end of the intervention.

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

成本效益分析(中期分析之后)

指标类型:

次要指标 

Outcome:

Cost effectiveness analyses (after the interim analysis)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物的副作用

指标类型:

次要指标 

Outcome:

Side effects

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

先天性畸型

指标类型:

次要指标 

Outcome:

Congenital abnormalities

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠并发症

指标类型:

次要指标 

Outcome:

Pregnancy complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3岁以下儿童的体格发育参数与神经发育情况

指标类型:

次要指标 

Outcome:

Physical growth parameters and neurological development of children up to 3 years of age

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 40 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由北京中医药大学刘建平教授产生随机序列。

Randomization Procedure (please state who generates the random number sequence and by what method):

Professor Liu Jianping, Beijing university of Chinese medicine, generates the random number sequence.

盲法:

双盲

Blinding:

Double blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

数据待录入,将录入在medresman平台, http://www.medresman.org.cn。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The data will be put into medresman, http://www.medresman.org.cn.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据采集和管理采用纸质版CRF与电子采集和管理系统同时进行。电子数据采集平台采用ResMan系统。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Data collection and management are carried out by paper CRF and electronic data collection and management system. ResMan system is adopted in electronic data collection.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-01
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