ChiCTR2100046084 版本V1.1 版本创建时间2021/12/14 01:31:56 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：

 ChiCTR2100046084 

最近更新日期：

Date of Last Refreshed on：

 2021-05-04 03:50:37 

注册时间：

Date of Registration：

 2021-05-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Evaluation of Health-Related Quality-of-Life for women with Polycystic Ovary Syndrome (PCOS)

Public title：

Evaluation of Health-Related Quality-of-Life for women with Polycystic Ovary Syndrome (PCOS)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Evaluation of Health-Related Quality-of-Life for women with Polycystic Ovary Syndrome (PCOS)

Scientific title：

Evaluation of Health-Related Quality-of-Life for women with Polycystic Ovary Syndrome (PCOS)

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：

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 35051537

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：

 elaineng@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 sterope7@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：

Room 3EF, 3/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

研究负责人通讯地址：

1/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Applicant address：

Room 3EF, 3/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

1/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., 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：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

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：

 CREC- 2021.109

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：

The 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：

 2021-03-31 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

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：

1/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Primary sponsor's address：

1/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, 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)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學

具体地址：

1/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

1/F, Block E, Special Block, Ngan Shing Street, Prince of Wales Hospital, Shatin, N.T., Hong Kong

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

PCOS  

Target disease：

PCOS

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

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

1. To evaluate HRQoL in Chinese women with PCOS using the Chinese-validated version of the PCOSQ. 2. To evaluate the responsiveness of the Chinese-validated version of the PCOSQ in women with PCOS who has undergone treatment. 3. To evaluate the minimal important differences of the Chinese-validated version of the PCOSQ in women with PCOS who has undergone treatment.  

Objectives of Study：

1. To evaluate HRQoL in Chinese women with PCOS using the Chinese-validated version of the PCOSQ. 2. To evaluate the responsiveness of the Chinese-validated version of the PCOSQ in women with PCOS who has undergone treatment. 3. To evaluate the minimal important differences of the Chinese-validated version of the PCOSQ in women with PCOS who has undergone treatment.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Oligo- and/or anovulation;
2. Clinical and/or biochemical signs of hyperandrogenism;
3. Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumours, Cushing's syndrome). For those adolescents who are less than 18 years old, fulfilling 3 out 3 criteria will be required to be diagnosed as having PCOS as proposed by the recent ESHRE/ARSM proposed Rotterdam criteria in 2012.

Inclusion criteria

All women aged 16 years or older with a diagnosis of PCOS will be recruited to join the study. PCOS is defined according to the Rotterdam consensus in 2003. Any 2 out of the following 3 criteria will be considered as having PCOS:
1. Oligo- and/or anovulation;
2. Clinical and/or biochemical signs of hyperandrogenism;
3. Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumours, Cushing's syndrome). For those adolescents who are less than 18 years old, fulfilling 3 out 3 criteria will be required to be diagnosed as having PCOS as proposed by the recent ESHRE/ARSM proposed Rotterdam criteria in 2012.

排除标准：

Those who are known to have cognitive or developmental disabilities, and could not come back for the visits will be excluded from the study.

Exclusion criteria：

Those who are known to have cognitive or developmental disabilities, and could not come back for the visits will be excluded from the study.

研究实施时间：

Study execute time：

从 From 2021-05-03 00:00:00至 To 2023-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-05-03 00:00:00 至 To 2023-08-31 00:00:00

干预措施：

Interventions：

组别：

PCOS cases

样本量：

 153

Group：

PCOS cases

Sample size：

干预措施：

No

干预措施代码：

Intervention：

NA

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：

  

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

PCOSQ Score

指标类型：

主要指标

Outcome：

PCOSQ Score

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：

组织：

Sample Name：

blood

Tissue：

NA

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

10 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 16 岁 years
最大 Max age 40 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）：

No

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

Not an RCT, no need to have a randomization list

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）：

N/A

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

NA

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：

To ensure anonymity, all participants will be identified by code numbers instead of names. In addition, all the data collected from the study will only be accessed by authorized personnel and they will be discarded after data analysis. The computer data will also be encrypted to maximize data security. All investigations including blood tests, ultrasound examinations will not cause any adverse effects on the women, and will in no way interfere with the clinical management of the patient. Hence there should be no problem anticipated in the collection of the data. Patients have the right to withdraw from the study at any time without prejudice to their subsequent medical care.

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

To ensure anonymity, all participants will be identified by code numbers instead of names. In addition, all the data collected from the study will only be accessed by authorized personnel and they will be discarded after data analysis. The computer data will also be encrypted to maximize data security. All investigations including blood tests, ultrasound examinations will not cause any adverse effects on the women, and will in no way interfere with the clinical management of the patient. Hence there should be no problem anticipated in the collection of the data. Patients have the right to withdraw from the study at any time without prejudice to their subsequent medical care.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-05-04 03:50:20