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Shedding of SARS-CoV-2 in human semen and evaluation of reproductive health of novel coronavirus pneumonia (COVID-19) male patients
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注册号:

Registration number:

ChiCTR2000030716 

最近更新日期:

Date of Last Refreshed on:

2020-03-12 

注册时间:

Date of Registration:

2020-03-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)男性精液“藏匿”病毒及生育健康评估 

Public title:

Shedding of SARS-CoV-2 in human semen and evaluation of reproductive health of novel coronavirus pneumonia (COVID-19) male patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

SARS-CoV-2感染男性精液“藏匿”病毒及生育健康评估 

Scientific title:

Shedding of SARS-CoV-2 in human semen and reproductive health evaluation of ever infected males 

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:

李红钢 

研究负责人:

李红钢 

Applicant:

HONGGANG LI 

Study leader:

HONGGANG LI 

申请注册联系人电话:

Applicant telephone:

+86 13871402927 

研究负责人电话:

Study leader's telephone:

+86 13871402927 

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:

lhgyx@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

lhgyx@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:

中国湖北武汉市航空路13号同济医学院生殖健康研究所 

研究负责人通讯地址:

中国湖北武汉市航空路13号同济医学院生殖健康研究所 

Applicant address:

13 Hangkong Road, Qiaokou District, Wuhan, Hubei, China 

Study leader's address:

13 Hangkong Road, Qiaokou District, Wuhan, Hubei, 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:

华中科技大学 

Applicant's institution:

Huazhong University of Science and Technology 

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:

2020伦审字001 

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:

华中科技大学同济医学院生殖医学中心医学科学研究伦理委员会 

Name of the ethic committee:

Medical Research Ethic committee of the Center of Reproductive Medicine, Tongji Medical College, HUST 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-21 

伦理委员会联系人:

张桦 

Contact Name of the ethic committee:

Zhang Hua 

伦理委员会联系地址:

武汉市三阳路13号三阳广场 

Contact Address of the ethic committee:

Shanyang Plaza, 13 Sanyang Road, Wuhan, Hubei, 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:

华中科技大学同济医学院 

Primary sponsor:

Tongji Medical College, HUST 

研究实施负责(组长)单位地址:

武汉市航空路13号 

Primary sponsor's address:

13 Hangkong Road, Qiaokou District, Wuhan, Hubei, 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):

湖北省

市(区县):

武汉市

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

华中科技大学同济医学院

具体地址:

武汉市航空路13号

Institution
hospital:

Tongji Medical College, HUST

Address:

13 Hangkong Road, Wuhan

经费或物资来源:

中央高校基本科研业务费专项 

Source(s) of funding:

Fundamental Research Funds for the Central University 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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:

1.SARS-CoV-2病毒是否存在于精液中; 2.康复后生育健康评估。 

Objectives of Study:

1. The presence of SARS-CoV-2 in human semen; 2. Reproductive Health evaluation in recovered males.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

确诊COVID-19男性患者50人,康复后患者100人,年龄22-55岁。 

Inclusion criteria

Men with diagnosed COVID-19, aged 22-55 years old. 50 inpatients and 100 males after recovery.  

排除标准:

症状重患者 

Exclusion criteria:

Severe patients 

研究实施时间:

Study execute time:

From2020-03-11To 2020-06-30 

征募观察对象时间:

Recruiting time:

From2020-03-05To 2020-05-31 

干预措施:

Interventions:

组别:

住院期间

样本量:

50

Group:

in hospital

Sample size:

干预措施:

精液病毒检测

干预措施代码:

Intervention:

Virus detection in semen

Intervention code:

组别:

康复后

样本量:

100

Group:

Recovered

Sample size:

干预措施:

性激素和精液质量检测

干预措施代码:

Intervention:

Hormones and sperm quality

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院生殖医学中心 

单位级别:

专科医院 

Institution
hospital:

Center of Reproductive Medicine, Tongji Medical College, HUST  

Level of the institution:

Specialized hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三甲医院 

Institution
hospital:

Union hospital, Tongji Medical College, HUST  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒

指标类型:

主要指标 

Outcome:

SARS-CoV-2 virus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性激素

指标类型:

主要指标 

Outcome:

sex hormones

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

精子质量

指标类型:

主要指标 

Outcome:

sperm quality

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:

精液

组织:

Sample Name:

semen

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血液

组织:

Sample Name:

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 22 years
最大 Max age 55 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):

本研究不需随机。

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

not applicable.

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

论文发表时作为附件,或联系负责人获取lhgyx@hotmail.com

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

supplement file upon publication or get via lhgyx@hotmail.com

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:

电子采集和管理系统

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

Electronic data capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-11
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