注册号: Registration number: |
ChiCTR1900021032 |
最近更新日期: Date of Last Refreshed on: |
2019-01-25 |
注册时间: Date of Registration: |
2019-01-03 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
生育狀況檢測問卷 |
Public title: |
Development and Validation of a Fertility Status Awareness Tool to Access the Fertility Problem among Hong Kong Chinese |
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: |
生育狀況檢測問卷 |
Scientific title: |
Development and Validation of a Fertility Status Awareness Tool to Access the Fertility Problem among Hong Kong Chinese |
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: |
CUHK_CCRB00642 |
申请注册联系人: |
Elaine NG |
研究负责人: |
CHUNG Pui Wah, Jacqueline |
Applicant: |
Elaine NG |
Study leader: |
CHUNG Pui Wah, Jacqueline |
申请注册联系人电话: Applicant telephone: |
+852 35052745 |
研究负责人电话: Study leader's telephone: |
+852 35052585 |
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: |
elaineng@link.cuhk.edu.hk |
研究负责人电子邮件: Study leader's E-mail: |
jacquelinechung@cuhk.edu.hk |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
https://www2.ccrb.cuhk.edu.hk/registry/public/586 |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
https://www2.ccrb.cuhk.edu.hk/registry/public/586 |
申请注册联系人通讯地址: |
Room 3EF, 3/F, Special Block EF, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong, China |
研究负责人通讯地址: |
1E, 1/F, Special Block EF, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong, China |
Applicant address: |
Room 3EF, 3/F, Special Block EF, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong, China |
Study leader's address: |
1E, 1/F, Special Block EF, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong, 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: |
香港中文大學婦產科學系 |
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Applicant's institution: |
Department of O&G, CUHK |
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: |
2018.482 |
伦理委员会批件附件: Approved file of Ethical Committee: |
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批准本研究的伦理委员会名称: |
Joint CUHK-NTEC Clinical Research Ethics Committee |
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Name of the ethic committee: |
Joint CUHK-NTEC Clinical Research Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2018-11-19 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
香港中文大學婦產科學系 |
Primary sponsor: |
Department of O&G, CUHK |
研究实施负责(组长)单位地址: |
Room 3EF, 3/F, Special Block EF, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong, China |
Primary sponsor's address: |
Room 3EF, 3/F, Special Block EF, Prince of Wales Hospital, Sha Tin, New Territories, Hong Kong, China |
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: |
Nil |
Source(s) of funding: |
Nil |
研究疾病: |
生育狀況 |
Target disease: |
Fertility Problem |
研究疾病代码: |
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Target disease code: |
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研究类型: |
病因学/相关因素研究 |
Study type: |
Cause/Relative factors study |
研究所处阶段: |
其它 |
Study phase: |
N/A |
研究目的: |
Development and Validation of a Fertility Status Awareness Tool to Access the Fertility Problem |
Objectives of Study: |
Development and Validation of a Fertility Status Awareness Tool to Access the Fertility Problem |
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: |
横断面 |
Study design: |
Cross-sectional |
纳入标准: |
(1) Hong Kong Chinese with Hong Kong Identity Card; (2) aged ≥ 18 years old; (3) able to speak Cantonese; (4) currently pregnant or meeting the clinical criteria for referral for infertility diagnosis; (5) able to give informed verbal consent. |
Inclusion criteria |
(1) Hong Kong Chinese with Hong Kong Identity Card; (2) aged ≥ 18 years old; (3) able to speak Cantonese; (4) currently pregnant or meeting the clinical criteria for referral for infertility diagnosis; (5) able to give informed verbal consent. |
排除标准: |
Exclusion criteria include those with age above 45 years old, unable to speak Cantonese, neither pregnant nor meeting the clinical criteria for referral for infertility diagnosis, and unable to understand and give informed verbal consent for the study. |
Exclusion criteria: |
Exclusion criteria include those with age above 45 years old, unable to speak Cantonese, neither pregnant nor meeting the clinical criteria for referral for infertility diagnosis, and unable to understand and give informed verbal consent for the study. |
研究实施时间: Study execute time: |
从From至To |
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): |
N/A |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
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 ater
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原始数据公开时间: The time of sharing IPD: |
Real time access |
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): |
未说明 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Not stated |
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: |
未说明 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Not stated |
数据管理委员会: Data Managemen Committee: |
有/Yes |