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基于多模态fMRI研究调经促孕针法对早发性卵巢功能不全患者下丘脑功能连接的影响
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注册号:

Registration number:

ChiCTR1900024684 

最近更新日期:

Date of Last Refreshed on:

2019-07-21 

注册时间:

Date of Registration:

2019-07-21 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于多模态fMRI研究调经促孕针法对早发性卵巢功能不全患者下丘脑功能连接的影响 

Public title:

Effect of Tiaojing Cuyun acupuncture on hypothalamic functional connectivity in patients with primary ovarian insufficiency based on multimodal functional magnetic resonance imaging 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于多模态fMRI研究调经促孕针法对早发性卵巢功能不全患者下丘脑功能连接的影响 

Scientific title:

Effect of Tiaojing Cuyun acupuncture on hypothalamic functional connectivity in patients with primary ovarian insufficiency based on multimodal functional magnetic resonance imaging 

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:

裴丽霞 

研究负责人:

孙建华 

Applicant:

Lixia Pei 

Study leader:

Jianhua Sun 

申请注册联系人电话:

Applicant telephone:

+86 18652098600 

研究负责人电话:

Study leader's telephone:

+86 13914722816 

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:

11801758@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

377201634@qq.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:

江苏省南京市建邺区汉中路155号 

研究负责人通讯地址:

江苏省南京市建邺区汉中路155号 

Applicant address:

155 Hanzhong Road, Jianye District, Nanjing, Jiangsu, China 

Study leader's address:

155 Hanzhong Road, Jianye District, Nanjing, Jiangsu, 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:

江苏省中医院 

Applicant's institution:

Jiangsu Provincial Traditional Chinese Medicine Hospital 

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:

2019NL-070-02 

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:

南京中医药大学附属医院(江苏省中医院)伦理委员会 

Name of the ethic committee:

Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Provincial Traditional Chinese Medicine Hospital) 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-06-15 

伦理委员会联系人:

吴静 

Contact Name of the ethic committee:

Jing Wu 

伦理委员会联系地址:

江苏省南京市建邺区汉中路155号 

Contact Address of the ethic committee:

155 Hanzhong Road, Jianye District, Nanjing, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 025-86560515 

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:

江苏省中医院 

Primary sponsor:

Jiangsu Provincial Traditional Chinese Medicine Hospital 

研究实施负责(组长)单位地址:

江苏省南京市建邺区汉中路155号 

Primary sponsor's address:

155 Hanzhong Road, Jianye District, Nanjing, Jiangsu, 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):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

江苏省中医院

具体地址:

建邺区汉中路155号

Institution
hospital:

Jiangsu Provincial Traditional Chinese Medicine Hospital

Address:

155 Hanzhong Road, Jianye District

经费或物资来源:

江苏省中医院 

Source(s) of funding:

Jiangsu Provincial Traditional Chinese Medicine Hospital 

研究疾病:

早发性卵巢功能不全 

Target disease:

Premature ovarian insufficiency 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

1.主要目的:比较POI患者与健康志愿者下丘脑功能连接差异,探索POI患者的下丘脑功能连接差异,以期寻找到中枢关键节点或者脑区。 2.次要目的:分析调经促孕针法对POI下丘脑功能连接的影响,及与临床疗效转归的关系,以期采用可视化的现代影像学技术期阐述调经促孕针法治疗POI的中枢机制。 

Objectives of Study:

1. The main purpose: to compare the difference in hypothalamic functional connectivity between POI patients and healthy volunteers, to explore the differences in hypothalamic functional connectivity in patients with POI, in order to find the key nodes or brain regions of the central nervous system. 2. Secondary purpose: to analyze the effect of menstruation and pro-pregnancy acupuncture on the function of POI hypothalamic function, and the relationship with clinical outcomes, in order to explain the central mechanism of treatment of POI by menstruation and pregnancy-promoting acupuncture using a visualized modern imaging technique.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

POI患者纳入标准: 1. 符合POI诊断标准; 2. 年龄在18~40岁之间,女性,右利手; 3. 近2个月未接受针对POI的针灸治疗,未参加其它正在进行的临床研究者; 4. 知情同意,志愿受试。获得知情同意书过程应符合GCP规定。 健康志愿者纳入标准: 1. 年龄18-40岁,女性,右利手,年龄均与POI患者相匹配; 2. 身体健康,无家族性精神病遗传史,无幽闭恐惧症; 3. 体内不能有影响功能磁共振检查的金属物质; 4. 女性志愿者未处于孕期、产后哺乳期; 5. 签署知情同意书,自愿参加研究。 

Inclusion criteria

The study will enroll patients with a diagnosis of POI who meets the following inclusion criteria: (1) patients meeting the ESHRE Guideline diagnostic criteria for POI, right-handed; (2) women between the ages of 18 and 40 years; (3) and no acupuncture therapy within 2 months prior to study recruitment; (4) sign the informed consent form and willing to participate in the study; Patients meeting the following criteria will be selected as study volunteers: (1) right-handed women between the ages of 18 and 40, age matched with POI patients; (2) good health, no genetic history of familial psychosis, no claustrophobia; (3) no metal substances in the body that affect functional magnetic resonance examination; (4) not in pregnancy, postpartum lactation; (5) sign the informed consent form and volunteer to participate in the study. 

排除标准:

1. 先天性生殖器官发育异常,或子宫、双侧卵巢或双侧输卵管切除患者;合并有心血管、肾、肝和造血系统等严重原发性疾病; 2. 多囊卵巢综合征、高催乳素血症、高雄激素血症者、甲状腺功能减退、慢性肾上腺皮质功能减退等内分泌疾病影响排卵者; 3. 安装心脏起搏器,金属过敏或严重惧针者;有幽闭恐惧症者; 4. 由于智力或行为障碍,不能配合完成临床观察者; 5. 根据研究者的判断易造成失访的患者,如工作环境经常变动、生活环境不稳定等; 6. 正在参加其他药物临床试验的患者。 

Exclusion criteria:

Patients meeting any of the following criteria will be excluded from the study: 1. abnormal development of congenital reproductive organs, or uterus, bilateral ovarian or bilateral salpingectomy, combined with severe primary diseases such as cardiovascular, renal, hepatic and hematopoietic systems; 2. endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, and chronic adrenal insufficiency affect ovulation; 3. install a pacemaker, metal allergy or severe fear of the needle, claustrophobia; 4. mental or behavioral disorders that do not match the completion of clinical observations; 5. patients who are likely to be lost to follow-up according to the judgment of the investigator, such as patients whose work environment changes frequently, whose living environment is unstable; 6. who are participating in other drug clinical trials. 

研究实施时间:

Study execute time:

From2019-07-31To 2020-12-31 

干预措施:

Interventions:

组别:

针刺组

样本量:

21

Group:

acupuncture group

Sample size:

干预措施:

调经促孕针刺

干预措施代码:

Intervention:

Tiaojing Cuyun acupuncture

Intervention code:

组别:

健康对照组

样本量:

21

Group:

healthy control group

Sample size:

干预措施:

no

干预措施代码:

Intervention:

不进行任何干预

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏省 

市(区县):

南京市 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

江苏省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Jiangsu Provincial Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

针刺干预12周下丘脑功能连接影像学改变

指标类型:

主要指标 

Outcome:

the hypothalamic functional connectivity imaging data obtained by fMRI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

窦卵泡计数

指标类型:

次要指标 

Outcome:

Antral follicle count

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵泡刺激素

指标类型:

次要指标 

Outcome:

Follicle stimulating hormone

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促黄体生成素水平

指标类型:

次要指标 

Outcome:

Luteinizing hormone

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孕酮

指标类型:

次要指标 

Outcome:

Progesterone

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清基础雌二醇

指标类型:

次要指标 

Outcome:

Estradiol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睾酮

指标类型:

次要指标 

Outcome:

Testosterone

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

催乳激素

指标类型:

次要指标 

Outcome:

prolactin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

更年期评分

指标类型:

次要指标 

Outcome:

kupperman

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑SAS评分

指标类型:

次要指标 

Outcome:

Self-rating anxiety scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

月经情况

指标类型:

次要指标 

Outcome:

Menstrual conditions

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠情况

指标类型:

次要指标 

Outcome:

Pregnancy

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗缪勒激素

指标类型:

次要指标 

Outcome:

Anti-müllerian hormone

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:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 18 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):

不采用随机方法

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

There is no randomization.

盲法:

N/A

Blinding:

N/A

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):

试验完成后6个月内,通过中国临床试验注册中心的ReaMan平台进行原始数据的共享 (http://www.medresman.org/login.aspx)

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

With 6 months after the trial complet, we will share IPD metadata and protocol based on the ReaMan platform (http://www.medresman.org/login.aspx)

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:

通过纸质CRF表格记录原始数据,再由两人交叉核对数据.

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

The records of metadata are recorded through a CRF form, and then cross-checked.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-07-21
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