ChiCTR1900023045 版本V1.0 版本创建时间2019/05/08 21:17:59 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR1900023045 

最近更新日期：

Date of Last Refreshed on：

 2019-05-08 20:48:25 

注册时间：

Date of Registration：

 2019-05-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中國傳統醫藥五子衍宗丸對不佳精液質素的影響研究

Public title：

A study for the relation among morphokinetic parameters, mitochondrial pattern and karyotype for better selection of embryos undergoing in vitro maturation

注册题目简写：

English Acronym：

IVM and Biopsy

研究课题的正式科学名称：

中國傳統醫藥五子衍宗丸對不佳精液質素的影響研究

Scientific title：

A study for the relation among morphokinetic parameters, mitochondrial pattern and karyotype for better selection of embryos undergoing in vitro maturation

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 35053199

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EF區1樓4室

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EF區1樓4室

Applicant address：

Office 4, 1F, Block EF (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T., China

Study leader's address：

Office 4, 1F, Block EF (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T., 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：

香港中文大學婦產科學系

Applicant's institution：

Department of Obstetric 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 Obstetric 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：

 2017.111

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 CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-02-03 00:00:00

伦理委员会联系人：

Ms. Jenny NG

Contact Name of the ethic committee：

Ms. 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香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35056307

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

香港中文大學婦產科學系

Primary sponsor：

Department of Obstetrics and Gynaecology, 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EF區1樓4室

Primary sponsor's address：

1F, Block EF (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T., 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：

威爾士親王醫院

Institution
hospital：

Prince of Wales Hospital

Address：

Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T., Hong Kong

经费或物资来源：

No fuding

Source(s) of funding：

No fuding

研究疾病：

In vitro oocyte maturation  

Target disease：

In vitro oocyte maturation

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：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

The aim of this study is to investigate the relations among morphokinetic parameters, mitochondria patterns and karyotype in order to decrease both the implantation failure rate and miscarriage rate of IVM embryos. The primary outcome of this study is to utilize the immature oocytes to increase the number of available embryo for improving the success rate of IVF by identifying the cytogenetic abnormal embryo through morphokinetic parameters. The second outcome is that we can increase our knowledge of meiotic error by studying the morphokinetic parameters and karyotype of immature oocytes.  

Objectives of Study：

The aim of this study is to investigate the relations among morphokinetic parameters, mitochondria patterns and karyotype in order to decrease both the implantation failure rate and miscarriage rate of IVM embryos. The primary outcome of this study is to utilize the immature oocytes to increase the number of available embryo for improving the success rate of IVF by identifying the cytogenetic abnormal embryo through morphokinetic parameters. The second outcome is that we can increase our knowledge of meiotic error by studying the morphokinetic parameters and karyotype of immature oocytes.

药物成份或治疗方案详述：

Our question of interest is whether there will be correlation betweenamong MP, mitochondria patterns and karyotype abnormality of immature oocytes undergoing IVM. In our study, the IVM protocol is just like the routine ICSI procedure: cumulus cells are removed 2-3h following oocyte retrieval using hyaluronidase and by careful mechanical denudation. The denuded oocytes are accessed by microscope by two trained observers. Oocytes in GV or MI phrases are considered immature oocytes. Any disagreement will be resolved by the adjudicating senior embryologist. We first culture the immature oocytes after denudation with IVM medium in Embryoscope, an incubator with time-lapse scope. From our previous study (not published), we found the timing of first body extrusion is from 275 minutes to 2450 minutes after denudation so we plan to investigate oocytes every 300 minutes after culturing in Embryoscope. If there are less than three oocytes extruded first polarbody during the time schedule, they will be considered as control group, which will not be performed ICSI. The material of control group including oocyte, polarbody, and their culture medium will go through methylomic, genomic and transcriptomic analyses. Once there are more than three oocytes extruded first polar body, we perform ICSI on the oocytes using the patients husband sperm. Then the fertilized oocyte will be placed to another culture slide with cleavage culture medium. The in vitro mature process will continue 2500 minutes after denudation. Then we use time-lapse equipment observe the fertilized oocyte until 72h after performed ICSI. 

Description for medicine or protocol of treatment in detail：

Our question of interest is whether there will be correlation betweenamong MP, mitochondria patterns and karyotype abnormality of immature oocytes undergoing IVM. In our study, the IVM protocol is just like the routine ICSI procedure: cumulus cells are removed 2-3h following oocyte retrieval using hyaluronidase and by careful mechanical denudation. The denuded oocytes are accessed by microscope by two trained observers. Oocytes in GV or MI phrases are considered immature oocytes. Any disagreement will be resolved by the adjudicating senior embryologist. We first culture the immature oocytes after denudation with IVM medium in Embryoscope, an incubator with time-lapse scope. From our previous study (not published), we found the timing of first body extrusion is from 275 minutes to 2450 minutes after denudation so we plan to investigate oocytes every 300 minutes after culturing in Embryoscope. If there are less than three oocytes extruded first polarbody during the time schedule, they will be considered as control group, which will not be performed ICSI. The material of control group including oocyte, polarbody, and their culture medium will go through methylomic, genomic and transcriptomic analyses. Once there are more than three oocytes extruded first polar body, we perform ICSI on the oocytes using the patients husband sperm. Then the fertilized oocyte will be placed to another culture slide with cleavage culture medium. The in vitro mature process will continue 2500 minutes after denudation. Then we use time-lapse equipment observe the fertilized oocyte until 72h after performed ICSI. 

纳入标准：

All patients complied to the following selection criteria:
1) plan to undergo ICSI procedure;
2) have immature oocyte/s after denudation; once recruited patients have more than three fertilized oocytes and extruded polar bodies, we will collect their polar bodies through polar body biopsy.

Inclusion criteria

All patients complied to the following selection criteria:
1) plan to undergo ICSI procedure;
2) have immature oocyte/s after denudation; once recruited patients have more than three fertilized oocytes and extruded polar bodies, we will collect their polar bodies through polar body biopsy.

排除标准：

1. male infertility due to one testicle had been removed, history of undescended testis, previous chemotherapy, testicular torsion;
2. Patients with azoospermia;
3. Patients with normal WHO (Version 5) in all parameters.

Exclusion criteria：

1. male infertility due to one testicle had been removed, history of undescended testis, previous chemotherapy, testicular torsion;
2. Patients with azoospermia;
3. Patients with normal WHO (Version 5) in all parameters.

研究实施时间：

Study execute time：

从 From 2019-06-01 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：

 100

Group：

Case series

Sample size：

干预措施：

MP, mitochondira, karyotype test

干预措施代码：

Intervention：

MP, mitochondira, karyotype test

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：

Shatin

单位(医院)：

 威爾士親王醫院 

单位级别：

 威爾士親王醫院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

Morphokinitic parameters

指标类型：

主要指标

Outcome：

Morphokinitic parameters

Type：

Primary indicator

测量时间点：

D0 and D1

测量方法：

Measure time point of outcome：

D0 and D1

Measure method：

指标中文名：

Mitochondria test

指标类型：

附加指标

Outcome：

Mitochondria test

Type：

Additional indicator

测量时间点：

After Biopsy

测量方法：

Mitochondria Test Kits

Measure time point of outcome：

After Biopsy

Measure method：

Mitochondria Test Kits

指标中文名：

Karyotyping

指标类型：

次要指标

Outcome：

Karyotyping

Type：

Secondary indicator

测量时间点：

After Biopsy

测量方法：

NGS

Measure time point of outcome：

After Biopsy

Measure method：

NGS

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Polarbody

组织：

Sample Name：

Polarbody

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

stored for ten years

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

stored for ten years

标本中文名：

Abnormal fertilized zygote

组织：

Sample Name：

Abnormal fertilized zygote

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

stored for ten years

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男性

Gender：

Male

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)：

No randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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

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：

有/Yes

注册人：

Name of Registration：

  2019-05-08 20:48:25