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胚胎冻融过程中卵裂球丢失对胚胎移植结局及子代健康的影响
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注册号:

Registration number:

ChiCTR-OOC-16007753 

最近更新日期:

Date of Last Refreshed on:

2016-01-13 

注册时间:

Date of Registration:

2016-01-13 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

胚胎冻融过程中卵裂球丢失对胚胎移植结局及子代健康的影响 

Public title:

The effect of blastomere loss during frozen embryo transfer on IVF outcome and offspring's health 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人类早期胚胎冻融过程中卵裂球丢失对胚胎移植结局及子代健康的影响及其机制研究 

Scientific title:

The effect of blastomere loss during frozen embryo transfer on IVF outcome and offspring's health and the underlying mechanism 

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:

吴琰婷 

研究负责人:

黄荷凤 

Applicant:

Yanting Wu 

Study leader:

Hefeng Huang 

申请注册联系人电话:

Applicant telephone:

+86 18621668988 

研究负责人电话:

Study leader's telephone:

+86 13906526300 

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:

yanting_wu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huanghefg@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:

上海市徐汇区衡山路910号 

研究负责人通讯地址:

上海市徐汇区衡山路910号5号楼2楼 

Applicant address:

910 Henghan Road, Shanghai 

Study leader's address:

910 Henghan Road, Shanghai 

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:

中国福利会国际和平妇幼保健院 

Applicant's institution:

The International Peace China welfare Institute, School of Medicine, Shanghai Jiao Tong 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:

国生殖伦委(2015)20号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

国际和平妇幼保健院生殖医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Reproductive Medicine, the International Peace Maternity and Child Health Hospital of China welfare Institute  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-09-03 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

中国福利会国际和平妇幼保健院 

Primary sponsor:

the International Peace Maternity and Child Health Hospital of China welfare Institute  

研究实施负责(组长)单位地址:

上海市徐汇区衡山路910 

Primary sponsor's address:

910 Henghan Road, Shanghai 

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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

中国福利会国际和平妇幼保健院

具体地址:

上海市徐汇区衡山路910

Institution
hospital:

the International Peace Maternity and Child Health Hospital of China welfare Institute

Address:

910 Henghan Road, Shanghai

经费或物资来源:

国家重大科学研究计划,国家自然科学基金 

Source(s) of funding:

he National Basic Research Program of China, the National Natural Science Foundation of China  

研究疾病:

冻融胚胎卵裂球丢失 

Target disease:

blastomere loss during frozen embryo transfer  

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:

明确植入前胚胎冻融过程中卵裂球丢失对单胎子代生长发育和智力发育的影响,进一步评估冻融胚胎卵裂球丢失的子代安全性;从基因组表达谱和甲基化图谱层面揭示早期胚胎冻融后卵裂球丢失对子代影响的分子机制。 

Objectives of Study:

The first objective of this study is to assess the effect of FET and blastomeres loss in human frozen-thawed embryo on the pregnancy and birth outcome. Moreover, we followed up the growth and intellectual development of singletons born from FET to evaluate the long-term impact of blastomeres loss on the offspring. The second aim is to investigatereveal the transcriptomic changes specifically associated with FET or blastomeres loss in offspring cord blood lymphocytes, and try to reveal the causal mechanism underlying adverse perinatal outcomes.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

实验组(丢失组)为同一FET周期中移植的胚胎均为卵裂球丢失的胚胎;对照组(完整组)为同一FET周期中移植的胚胎均为卵裂球完整的胚胎 

Inclusion criteria

According to the survival after cryopreservation, transferred embryos were split into two groups: transfers with all embryos having lost at least one blastomere (damage group) and transfers with all embryos intact (intact group).  

排除标准:

同时移植了完整和丢失胚胎的FET周期 

Exclusion criteria:

FET with both damage embryo and intact embryo. 

研究实施时间:

Study execute time:

From2015-09-03To 2018-07-01 

征募观察对象时间:

Recruiting time:

From2005-01-01To 2014-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

6000

Group:

Case series

Sample size:

干预措施:

冻融胚胎卵裂球

干预措施代码:

Intervention:

frozen-thawed embryo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

China 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

中国福利会国际和平妇幼保健院 

单位级别:

省级 

Institution
hospital:

the International Peace Maternity and Child Health Hospital of China welfare Institute  

Level of the institution:

province 

测量指标:

Outcomes:

指标中文名:

妊娠率

指标类型:

主要指标 

Outcome:

pregnancy rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出生体重

指标类型:

主要指标 

Outcome:

birth weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

儿童发育指数

指标类型:

主要指标 

Outcome:

Gesell Developmental Schedules

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中国韦氏智商

指标类型:

主要指标 

Outcome:

Chinese Wechsler Intelligence Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新生儿脐带血转录谱

指标类型:

主要指标 

Outcome:

RNA-Seq transcriptome of offspring’s umbilical cord blood

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:

新生儿脐带血

组织:

Sample Name:

offspring’s umbilical cord 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 2 years
最大 Max age 14 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

NA

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

NA

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):

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):

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

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:

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

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:

 2016-01-13
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