今天是:2019-10-22 星期二

针灸治疗多囊卵巢综合征致不孕症疗效评价
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注册号:

Registration number:

ChiCTR1800014997 

最近更新日期:

Date of Last Refreshed on:

2018-02-27 

注册时间:

Date of Registration:

2018-02-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针灸治疗多囊卵巢综合征致不孕症疗效评价 

Public title:

Evaluation of the effect of acupuncture and moxibustion in the treatment of infertility caused by polycystic ovary syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针灸治疗多囊卵巢综合征致不孕症疗效评价 

Scientific title:

Evaluation of the effect of acupuncture and moxibustion in the treatment of infertility caused by polycystic ovary syndrome 

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:

 

申请注册联系人:

汪乔 

研究负责人:

殷岫绮 

Applicant:

Qiao Wang 

Study leader:

Xiuqi Yin 

申请注册联系人电话:

Applicant telephone:

+86 13122396281 

研究负责人电话:

Study leader's telephone:

+86 13701924968 

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:

349272639@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yin-xiuqi@163.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:

上海市浦东新区张江镇华佗路280弄 

研究负责人通讯地址:

上海市浦东张江高科技园区张衡路528号 

Applicant address:

280 Huatuo Road, Zhangjiang Town, Pudong New Area, Shanghai, China 

Study leader's address:

528 Zhangheng Road, Zhangjiang Hi-tech Park, Pudong, Shanghai, 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:

上海中医药大学 

Applicant's institution:

Shanghai University of Traditional 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:

2017-569-52-01 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

IRB of Shuguang Hospital affiliated with Shanghai University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-22 

伦理委员会联系人:

耿希 

Contact Name of the ethic committee:

Xi Geng 

伦理委员会联系地址:

上海市浦东张江高科技园区张衡路528号 

Contact Address of the ethic committee:

528 Zhangheng Road, Zhangjiang Hi-tech Park, Pudong, Shanghai, 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:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市浦东张江高科技园区张衡路528号 

Primary sponsor's address:

528 Zhangheng Road, Zhangjiang Hi-tech Park, Pudong, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

具体地址:

上海市浦东张江高科技园区张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Zhangjiang Hi-tech Park, Pudong, Shanghai, China

经费或物资来源:

上海中医药大学中医学学科项目 

Source(s) of funding:

Chinese medicine science project from Shanghai University of Traditional Chinese Medicine 

研究疾病:

多囊卵巢综合症致不孕症 

Target disease:

infertility caused by polycystic ovary syndrome 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评价中药联合针灸治疗多囊卵巢综合征致不孕症患者的作用,提高中医药治疗该病的缓解率和稳定率,降低治疗的副作用。 

Objectives of Study:

to evaluate the effect of Chinese medicine combined with acupuncture on infertility caused by polycystic ovary syndrome, and to improve the relief rate and stability rate of Chinese medicine for treating this disease, and reduce the side effects of treatment. 

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.年龄在20至40岁之间的已婚女性; 2.符合多囊卵巢综合征性不孕症诊断标准的患者; 3.排除其他不孕因素; 4.配偶精液常规检查正常; 5.签署知情同意书。 

Inclusion criteria

1. married women aged between 20 and 40 years old; 2. patients with the diagnostic criteria for polycystic ovarian syndrome; 3. exclusion of other infertility factors; 4. normal seminal semen examination was normal; 5. sign the informed consent. 

排除标准:

1.经诊断,西医诊断不是多囊卵巢综合征引起的不孕症患者; 2.高泌乳素血症、肾上腺或卵巢肿瘤分泌雄激素异常增多、甲状腺疾病、疑似库欣综合征及其他心肾疾病患者; 3.近1个月内使用过雌激素或口服避孕药等激素类药物; 4.近2个月内使用过其他影响生殖功能或代谢的药物(如抗肥胖药物、抗糖尿病药物以及中药等)或参加过其他临床试验的患者; 5.接受过针刺治疗; 6.合并其它不孕因素; 7.男方有不育症; 8.不能配合完成研究计划,包括有传染病、精神病及其他病史的患者。 

Exclusion criteria:

1. the diagnosis of Western medicine is not a case of infertility caused by polycystic ovary syndrome. 2. hyperprolactinemia, adrenal or ovarian tumors secreted androgenic abnormalities, thyroid diseases, suspected Cushing syndrome and other patients with heart and kidney disease; 3. hormone drugs such as estrogen or oral contraceptives have been used in the last 1 months; 4. in the past 2 months, other drugs that affect reproductive function or metabolism, such as anti obesity drugs, antidiabetic drugs and Chinese herbs, have been used in other clinical trials; 5. received acupuncture treatment; 6. combined with other infertility factors; 7. men have infertility; 8. do not cooperate with the completion of the research program, including patients with infectious diseases, psychosis and other medical history. 

研究实施时间:

Study execute time:

From2018-03-01To 2019-12-31 

干预措施:

Interventions:

组别:

非深刺激治疗组

样本量:

43

Group:

Non deep stimulation treatment group

Sample size:

干预措施:

安慰针

干预措施代码:

Intervention:

Consolation needle

Intervention code:

组别:

试验组

样本量:

43

Group:

Experimental group

Sample size:

干预措施:

中药联合针灸治疗

干预措施代码:

Intervention:

Chinese medicine combined with acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海市 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属曙光医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

排卵率

指标类型:

主要指标 

Outcome:

Ovulation rate

Type:

Primary 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:

正在进行

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):

由专门分组人员通过随机数字表进行随机分组

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

by a group of specialized groups through a random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020.1.30公开,原始数据

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

Jan,30,2020, metadata

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:病例记录表 数据管理:SPSS软件

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

Data collection:record Data management:SPSS

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-02-27
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