今天是:2022-07-06 星期三

应用二维斑点追踪技术观察人类辅助生殖受孕后代心室功能的变化
下载XML文档

注册号:

Registration number:

ChiCTR1900021672 

最近更新日期:

Date of Last Refreshed on:

2019-03-04 

注册时间:

Date of Registration:

2019-03-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

应用二维斑点追踪技术观察人类辅助生殖受孕后代心室功能的变化 

Public title:

Assessment of ventricular function of the offspring conceived by assisted reproductive technologies using two-dimensional speckle-tracking 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

应用二维斑点追踪技术观察人类辅助生殖受孕后代心室功能的变化 

Scientific title:

Assessment of ventricular function of the offspring conceived by assisted reproductive technologies using two-dimensional speckle-tracking 

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:

毕文静 

研究负责人:

毕文静 

Applicant:

Bi Wen-jing 

Study leader:

Bi Wen-jing 

申请注册联系人电话:

Applicant telephone:

+86 18940252701 

研究负责人电话:

Study leader's telephone:

+86 18940252701 

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:

bi.wenjing@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

bi.wenjing@hotmail.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:

沈阳市和平区三好街36号 

研究负责人通讯地址:

沈阳市和平区三好街36号 

Applicant address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, China 

Study leader's address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院 

Applicant's institution:

Shengjing Hospital of China Medical University 

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:

2018PS17K 

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:

中国医科大学附属盛京医院医学伦理委员会 

Name of the ethic committee:

the Medical Ethics Committee of Shengjing Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-01 

伦理委员会联系人:

赵玉虹 

Contact Name of the ethic committee:

Zhao Yu-hong 

伦理委员会联系地址:

沈阳市和平区三好街36号 

Contact Address of the ethic committee:

36 Sanhao Street, Heping District, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院 

Primary sponsor:

Shengjing Hospital of China Medical University 

研究实施负责(组长)单位地址:

沈阳市和平区三好街36号 

Primary sponsor's address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, 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):

辽宁省

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

中国医科大学附属盛京医院

具体地址:

沈阳市和平区三好街36号

Institution
hospital:

Shengjing Hospital of China Medical University

Address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, China

经费或物资来源:

无经费 

Source(s) of funding:

None 

研究疾病:

心室功能 

Target disease:

ventricular function 

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:

其它 

Study phase:

N/A 

研究目的:

观察人类辅助生殖受孕与正常受孕后代的心室功能是否存在差异。 

Objectives of Study:

Observation of differences in ventricular function between ART and normal pregnant offspring. 

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:

早期妊娠检查未发现胎儿异常。 

Inclusion criteria

Cases with a normal first-trimester scan. 

排除标准:

①胚胎着床前遗传学诊断;②卵母细胞捐赠;③孕妇患严重临床疾病,包括慢性高血压,糖尿病,心脏病,HIV,肝炎,狼疮,甲状腺疾病等;④多胎妊娠;⑤妊娠中后期检查发现胎儿畸形;⑥妊娠未满37周生产;⑦生产时新生儿体重在其期望值的第十百分位以下。 

Exclusion criteria:

1. preimplantation genetic diagnosis; 2. oocyte donation; 3. any important maternal medical disease; 4. multiple pregnancies; 5. later diagnosis of fetal malformations; 6. delivery before 37 weeks of gestation; 7. estimated fetal weight [EFW] by ultrasound lower than the 10th centiles. 

研究实施时间:

Study execute time:

From2017-12-01To 2019-11-30 

征募观察对象时间:

Recruiting time:

From2017-12-01To 2019-04-30 

干预措施:

Interventions:

组别:

辅助生殖受孕vs正常受孕后代

样本量:

200

Group:

ART versus normal pregnant offspring

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

沈阳市 

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 Hospital 

测量指标:

Outcomes:

指标中文名:

整体纵向应变

指标类型:

主要指标 

Outcome:

global longitudinal strain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

整体圆周应变

指标类型:

主要指标 

Outcome:

global circumferential strain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左心室扭转

指标类型:

主要指标 

Outcome:

Left ventricular torsion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

左心室解旋率

指标类型:

主要指标 

Outcome:

Left ventricular relaxation 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:

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 years
最大 Max age 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):

非随机试验

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

Non-randomized studies

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):

是否共享原始数据:

IPD sharing

否No

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):

ResMan (www.medresman.org)

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

ResMan (www.medresman.org)

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:

ResMan (www.medresman.org)

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

ResMan (www.medresman.org)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-03-04
返回列表