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A study for the relationship between novel morphology parameters and embryo development for better selection of embryos undergoing in vitro fertilization
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注册号：

Registration number：

 ChiCTR1900023021 

最近更新日期：

Date of Last Refreshed on：

 2019-05-07 22:02:01 

注册时间：

Date of Registration：

 2019-05-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A study for the relationship between novel morphology parameters and embryo development for better selection of embryos undergoing in vitro fertilization

Public title：

A study for the relationship between novel morphology parameters and embryo development for better selection of embryos undergoing in vitro fertilization

注册题目简写：

NMP in IVF

English Acronym：

NMP in IVF

研究课题的正式科学名称：

A study for the relationship between novel morphology parameters and embryo development for better selection of embryos undergoing in vitro fertilization

Scientific title：

A study for the relationship between novel morphology parameters and embryo development for better selection of embryos undergoing in vitro fertilization

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：

Zhao Mingpeng 

研究负责人：

Li Tin Chiu 

Applicant：

Zhao Mingpeng 

Study leader：

Li Tin Chiu 

申请注册联系人电话：

Applicant telephone：

 +852 60700086

研究负责人电话：

Study leader's
telephone：

+852 35051456

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：

 zhaomp@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 tinchiu.li@cuhk.edu.hk

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：

中國香港特別行政區新界沙田威爾士親王醫院

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院

Applicant address：

Special Block 1E, Prince of Wales Hospital, Shatin, Hong Kong, China

Study leader's address：

Special Block 1E, Prince of Wales Hospital, Shatin, Hong Kong

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：

香港中文大學婦產科學系

Applicant's institution：

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學婦產科學系

Affiliation of the Leader：

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

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：

 2017.580

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-11-07 00:00:00

伦理委员会联系人：

Jenny Ng

Contact Name of the ethic committee：

Jenny Ng

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, 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：

香港中文大學

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田威爾士親王醫院

Primary sponsor's address：

Special Block 1E, Prince of Wales Hospital, Shatin, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

沙田

Country：

China

Province：

Hong Kong Special Administrative Region

City：

Shatin

单位(医院)：

威爾士親王醫院

具体地址：

新界沙田威爾士親王醫院

Institution
hospital：

Prince of Wales Hospital

Address：

Prince of Wales Hospital, Shatin, Hong Kong

经费或物资来源：

无

Source(s) of funding：

No

研究疾病：

不育症  

Target disease：

Infertility

研究疾病代码：

Target disease code：

研究类型：

基础科学研究

Study type：

Basic Science

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

单臂 

Study design：

Single arm 

研究目的：

This study aims to investigate the relationship between morphology parameters and embryo development to find out novel morphology predictors for better embryo selection for patients undergoing in vitro fertilization. The primary outcome of this study is to see whether the novel morphology parameters including cytoplasm size, zona pellucida grayscale, and embryo roundness can predict the blastocyst formation rate, implantation rate, pregnancy rate of embryos. The second outcome is whether those novel morphology parameters can predict the fertilization rate and the high-scoring embryo rate.  

Objectives of Study：

This study aims to investigate the relationship between morphology parameters and embryo development to find out novel morphology predictors for better embryo selection for patients undergoing in vitro fertilization. The primary outcome of this study is to see whether the novel morphology parameters including cytoplasm size, zona pellucida grayscale, and embryo roundness can predict the blastocyst formation rate, implantation rate, pregnancy rate of embryos. The second outcome is whether those novel morphology parameters can predict the fertilization rate and the high-scoring embryo rate.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Their images captured by routine practice will be used for a detail observation of novel morphology parameters. And the embryos development outcomes will be analyzed retrospectively with those parameters. There are no exclusion criteria for patient selection.

Exclusion criteria：

Their images captured by routine practice will be used for a detail observation of novel morphology parameters. And the embryos development outcomes will be analyzed retrospectively with those parameters. There are no exclusion criteria for patient selection.

研究实施时间：

Study execute time：

从 From 2018-01-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-06-01 00:00:00 至 To 2020-12-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 120

Group：

Case series

Sample size：

干预措施：

morphology parameter

干预措施代码：

Intervention：

morphology parameter

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 威爾士親王醫院 

单位级别：

 三级医院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

囊胚形態

指标类型：

主要指标

Outcome：

Blastocyst formation

Type：

Primary indicator

测量时间点：

Day 5 or Day 6

测量方法：

Measure time point of outcome：

Day 5 or Day 6

Measure method：

指标中文名：

可用胚胎

指标类型：

次要指标

Outcome：

Available Embryos

Type：

Secondary indicator

测量时间点：

D3 or D5 or D6

测量方法：

Measure time point of outcome：

D3 or D5 or D6

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Images

组织：

Images

Sample Name：

Images

Tissue：

Images

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

10 years

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 岁 years
最大 Max age 岁 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）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

N/A

Blinding：

N/A

是否共享原始数据：

IPD sharing

是Yes

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）：

IPD will be public accessable via ResMan

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

IPD will be public accessable via ResMan

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：

All information the participant will be carefully recorded on the case report forms (CRF). All errors will be crossed out and corrected and signed by the corresponding investigator. The study data in the CRF will be entered and coded to a corresponding e-CRF by the double-entry method. Hard copy CRFs are stored in a separated room, locked in filing cabinets and only authorized investigators are permitted to access this information. The e-CRFs are stored in a server encrypted using the Advanced Encryption Standard and only authorized investigators are permitted to access them. The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data.

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

All information the participant will be carefully recorded on the case report forms (CRF). All errors will be crossed out and corrected and signed by the corresponding investigator. The study data in the CRF will be entered and coded to a corresponding e-CRF by the double-entry method. Hard copy CRFs are stored in a separated room, locked in filing cabinets and only authorized investigators are permitted to access this information. The e-CRFs are stored in a server encrypted using the Advanced Encryption Standard and only authorized investigators are permitted to access them. The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data.

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：

  2019-05-07 22:02:01
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