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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
中国医科大学附属盛京医院 |
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Applicant's institution: |
Shengjing Hospital of China Medical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
the Medical Ethics Committee of Shengjing Hospital of China Medical University |
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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 |
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Contact Name of the ethic committee: |
Zhao Yu-hong |
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伦理委员会联系地址: |
沈阳市和平区三好街36号 |
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Contact Address of the ethic committee: |
36 Sanhao Street, Heping District, Shenyang, Liaoning, China |
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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 |
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Primary sponsor: |
Shengjing Hospital of China Medical University |
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研究实施负责(组长)单位地址: |
沈阳市和平区三好街36号 |
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Primary sponsor's address: |
36 Sanhao Street, Heping District, Shenyang, Liaoning, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
无经费 |
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Source(s) of funding: |
None |
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研究疾病: |
心室功能 |
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Target disease: |
ventricular function |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
Study phase: |
N/A |
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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。 |
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Objectives of Study: |
Observation of differences in ventricular function between ART and normal pregnant offspring. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
析因分组(即根据危险因素或暴露因素分组) |
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Study design: |
Factorial |
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纳入标准: |
早期妊娠检查未发现胎儿异常。 |
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Inclusion criteria |
Cases with a normal first-trimester scan. |
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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。 |
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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: |
从From2017-12-01至To 2019-11-30 |
征募观察对象时间: Recruiting time: |
从From2017-12-01至To 2019-04-30 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
女性 |
Gender: |
Female |
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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 |
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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): |
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Calculated Results after
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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 |