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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

A Prospective Comparative Study on the Incidence of Late-Onset Hypogonadism in Male Occupational Populations Based on a Health Examination Cohort and the Development of a Risk Prediction Model

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注册号：

Registration number：

ChiCTR2600126375 

最近更新日期：

Date of Last Refreshed on：

2026-06-08 16:38:30 

注册时间：

Date of Registration：

2026-06-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于体检队列的男性职业人群迟发性性腺功能减退发生的前瞻性比较研究及风险预测模型构建

Public title：

A Prospective Comparative Study on the Incidence of Late-Onset Hypogonadism in Male Occupational Populations Based on a Health Examination Cohort and the Development of a Risk Prediction Model

注册题目简写：

男性职业人群雄激素下降风险的随访研究

English Acronym：

A Follow-up Study on the Risk of Declining Androgen Levels in Male Occupational Populations

研究课题的正式科学名称：

基于体检队列的男性职业人群迟发性性腺功能减退发生的前瞻性比较研究及风险预测模型构建

Scientific title：

A Prospective Comparative Study on the Incidence of Late-Onset Hypogonadism in Male Occupational Populations Based on a Health Examination Cohort and the Development of a Risk Prediction Model

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：

汤育新 

研究负责人：

汤育新 

Applicant：

Tang Yuxin 

Study leader：

Tangyuxin 

申请注册联系人电话：

Applicant telephone：

+86 137 8731 8086

研究负责人电话：

Study leader's telephone：

+86 137 8731 8086

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：

tangyx36@mail.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

mmcct@126.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：

珠海市香洲区梅华东路52号中山大学附属第五医院

研究负责人通讯地址：

珠海市香洲区梅华东路52号

Applicant address：

The Fifth Affiliated Hospital, Sun Yat-sen University, No. 52 Meihua East Road, Xiangzhou District,

Study leader's address：

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City

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：

中山大学附属第五医院

Applicant's institution：

The Fifth Affiliated Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学附属第五医院

Affiliation of the Leader：

Fifth Affiliated Hospital, Sun Yat-Sen University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

中山五院〔2026〕伦字第(K174-1)号

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：

中山大学附属第五医院医学伦理委员会

Name of the ethic committee：

The Fifth Affiliated Hospital Sun Yat sen University Committee on medical ethics

伦理委员会批准日期：

Date of approved by ethic committee：

2026-05-19 00:00:00

伦理委员会联系人：

傅雪婷

Contact Name of the ethic committee：

Fu XueTing

伦理委员会联系地址：

珠海市香洲区梅华东路52号

Contact Address of the ethic committee：

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 756 252 8895

伦理委员会联系人邮箱：

Contact email of the ethic committee：

813510375@qq.com

研究实施负责（组长）单位：

中山大学附属第五医院

Primary sponsor：

Fifth Affiliated Hospital, Sun Yat-Sen University

研究实施负责（组长）单位地址：

珠海市香洲区梅华东路52号

Primary sponsor's address：

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学附属第五医院

具体地址：

珠海市香洲区梅华东路52号

Institution
hospital：

Fifth Affiliated Hospital, Sun Yat-Sen University

Address：

No. 52, Meihua East Road, Xiangzhou District, Zhuhai City

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China (NSFC)

Target disease：

Late-onset hypogonadism

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：

队列研究 

Study design：

Cohort study 

研究目的：

本研究拟基于体检中心职业男性人群建立前瞻性观察性队列，比较公职人员与企业管理人员迟发性性腺功能减退（LOH）的基线患病情况及随访期间发生风险，分析其相关危险因素及职业特征影响，并进一步构建和验证 LOH 风险预测模型，为男性职业人群健康管理和早期筛查提供依据。  

Objectives of Study：

This study aims to establish a prospective observational cohort based on male occupational populations undergoing routine health examinations, compare the baseline prevalence and follow-up incidence of late-onset hypogonadism (LOH) between public-sector employees and enterprise managers, identify related risk factors and occupational influences, and further develop and validate a risk prediction model for LOH, so as to provide evidence for early screening and health management in male occupational populations.

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.自愿签署知情同意书；
2.年龄30-60岁；
3.性别男；
4.体检中心的固定体检人群，包括在职公职人员或大型企业中层及以上管理人员： 在职公职人员具体纳入标准：定义为在政府机关或事业单位中从事行政、管理或专业技术工作的在编或合同制男性人员。工作单位：政府机关（如行政部门、党政机关）、事业单位（如医院、学校、科研机构）；岗位性质：行政管理岗、专业技术岗、综合事务岗；职级范围：科员级及以上（或单位认可的管理/技术骨干岗位） 企业管理人员具体纳入标准：定义为在企业中承担管理职责或核心决策职责的人员。职务：部门负责人、中层管理、高级管理（如经理、总监等），或满足有直接下属 ≥3人，或参与部门决策、项目管理。
5.具有完全民事行为能力，能够理解研究内容；

Inclusion criteria

1.Voluntarily provide written informed consent;
2.Be male;
3.Aged 30–60 years;
4.Be a regular attendee of the health examination center, including either an actively employed public-sector employee or a middle- or senior-level manager in a large enterprise: Specific inclusion criteria for public-sector employees: defined as male employees, either on official establishment or contract-based, who are actively employed in government agencies or public institutions and engaged in administrative, managerial, or professional/technical work. Eligible work units include government agencies (such as administrative departments and Party/government organs) and public institutions (such as hospitals, schools, and research institutes). Eligible positions include administrative management posts, professional/technical posts, and general affairs posts. Eligible rank includes clerk level or above, or positions recognized by the employing unit as management or technical backbone roles. Specific inclusion criteria for enterprise managers: defined as individuals in enterprises who undertake managerial responsibilities or core decision-making responsibilities. Eligible positions include department heads, middle management, and senior management (such as managers and directors), or individuals who meet at least one of the following criteria: directly supervise three or more subordinates, or participate in departmental decision-making or project management.
5.Have full civil capacity and be able to understand the study content;

排除标准：

1.已确诊因先天性、创伤性、手术或肿瘤等原因导致的性腺功能减退；
2.有严重心、肝、肾功能不全或精神疾病史；
3.近期（3个月内）服用过性激素或影响性功能的药物，如阿片类镇痛药、抗抑郁药、糖皮质激素、外源性雄激素及其他可能影响性激素水平药；

Exclusion criteria：

1.Have a confirmed diagnosis of hypogonadism caused by congenital, traumatic, surgical, tumor-related, or other similar conditions;
2.Have a history of severe cardiac, hepatic, or renal insufficiency, or severe psychiatric disorders;
3.Have used sex hormones or medications that may affect sexual function within the past 3 months, including opioid analgesics, antidepressants, glucocorticoids, exogenous androgens, or other drugs that may influence sex hormone levels;

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2031-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-08 00:00:00 至 To 2027-05-31 00:00:00  

干预措施：

Interventions：

组别：

公职组

样本量：

2650

Group：

Public-sector employee group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

企业管理组

样本量：

2650

Group：

Enterprise manager group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学附属第五医院 

单位级别：

三级甲等 

Institution
hospital：

Fifth Affiliated Hospital, Sun Yat-Sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

勃起功能障碍情况

指标类型：

次要指标

Outcome：

Erectile dysfunction status

Type：

Secondary indicator

测量时间点：

基线及随访期间每年评估

测量方法：

采用国际勃起功能指数简表（IIEF-5）进行评估，总分 ≤21 分定义为勃起功能障碍，并可进一步分级分析。

Measure time point of outcome：

At baseline and annually during follow-up

Measure method：

Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5). A total score of 21 or below will be defined as erectile dysfunction, with further severity grading if applicable.

指标中文名：

随访期间迟发性性腺功能减退发生

指标类型：

主要指标

Outcome：

Incident late-onset hypogonadism during follow-up

Type：

Primary indicator

测量时间点：

基线及随访期间每年评估，重点记录 3–5 年内 LOH 新发情况

测量方法：

采用研究方案预设标准判定 LOH。结合 LOH 相关症状评估及清晨空腹血清总睾酮检测结果进行综合判定；随访期间出现符合标准者判定为新发 LOH。

Measure time point of outcome：

At baseline and annually during follow-up, with incident LOH assessed over 3–5 years

Measure method：

LOH will be defined according to the prespecified study criteria, based on symptom assessment together with morning fasting serum total testosterone measurement. Participants meeting the criteria during follow-up will be classified as incident LOH cases.

指标中文名：

基线迟发性性腺功能减退患病情况

指标类型：

次要指标

Outcome：

Baseline prevalence of late-onset hypogonadism

Type：

Secondary indicator

测量时间点：

基线

测量方法：

基线时通过 LOH 症状评估、体格检查及清晨空腹血清总睾酮检测综合判定 LOH 状态，并计算基线患病率。

Measure time point of outcome：

Baseline

Measure method：

At baseline, LOH status will be determined by symptom assessment, physical examination, and morning fasting serum total testosterone testing, and baseline prevalence will be calculated.

指标中文名：

LOH 风险预测模型性能

指标类型：

次要指标

Outcome：

Performance of the LOH risk prediction model

Type：

Secondary indicator

测量时间点：

随访结束后进行模型构建与验证

测量方法：

基于多因素分析结果构建 LOH 风险预测模型，并采用受试者工作特征曲线下面积（AUC）、校准曲线等指标评价模型区分度和校准度。

Measure time point of outcome：

After completion of follow-up, during model development and validation

Measure method：

A risk prediction model for LOH will be developed based on multivariable analysis. Model performance will be evaluated using the area under the receiver operating characteristic curve (AUC) and calibration assessment.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

静脉血

组织：

Sample Name：

Venous blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

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 30 岁 years
最大 Max age 60 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）：

无

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

None

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

No

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）：

本研究暂不公开共享个体原始数据（IPD）。主要原因为研究数据涉及受试者个人隐私及敏感健康信息，且需遵循知情同意及伦理审查要求。研究完成后，将以汇总分析结果、学术论文及会议报告等形式公开研究发现，不提供可识别个体信息的原始数据。

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

Individual participant data (IPD) from this study will not be publicly shared at this stage, because the dataset contains personal privacy and sensitive health information and is subject to informed consent and ethical requirements. After study completion, the main findings will be disseminated in the form of aggregated results, academic publications, and conference presentations, without disclosure of identifiable raw data.

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：

本研究采用标准化病例报告表（CRF）及电子数据库相结合的方式进行数据采集和管理。研究数据主要来源于受试者问卷调查、体格检查、实验室检测结果及随访记录。所有研究对象均采用唯一编码进行标识，个人身份信息与研究数据分开保存。纸质资料由专人保管于有权限控制的场所，电子数据录入后保存在受密码保护的数据库或医院授权服务器中，仅限研究团队授权成员访问。数据录入后将进行逻辑核查、完整性核查及必要的数据清理，确保数据准确性、一致性和可追溯性。研究结束后，数据将按医院及伦理要求规范保存和管理。

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

Study data will be collected and managed using standardized case report forms (CRFs) together with an electronic database. Data sources include questionnaires, physical examination results, laboratory test results, and follow-up records. Each participant will be assigned a unique study code, and personally identifiable information will be stored separately from research data. Paper records will be kept by designated staff in access-controlled locations, and electronic data will be stored in password-protected databases or institution-authorized servers accessible only to authorized study personnel. Logical checks, completeness checks, and data cleaning procedures will be performed to ensure data accuracy, consistency, and traceability. After study completion, data will be retained and managed in accordance with institutional and ethical requirements.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-08 16:38:24
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