ChiCTR2500107367 版本V1.0 版本创建时间2025/08/11 08:30:33 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：

ChiCTR2500107367 

最近更新日期：

Date of Last Refreshed on：

2025-08-11 08:30:12 

注册时间：

Date of Registration：

2025-08-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

不孕不育人群生殖道感染的预防及治疗前瞻性队列研究

Public title：

The prevention and treatment of reproductive tract infections in infertile couples: A prospective cohort study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

不孕不育人群生殖道感染的预防及治疗前瞻性队列研究

Scientific title：

The prevention and treatment of reproductive tract infections in infertile couples: A prospective cohort study

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：

杨继春 

研究负责人：

相立峰 

Applicant：

Jichun Yang 

Study leader：

LiFeng Xiang 

申请注册联系人电话：

Applicant telephone：

+86 151 9895 8256

研究负责人电话：

Study leader's telephone：

+86 151 9895 8256

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：

yangjichunya@163.com

研究负责人电子邮件：

Study leader's E-mail：

xlflotus@aliyun.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：

云南省昆明市西山区金碧路157号

研究负责人通讯地址：

云南省昆明市西山区金碧路157号

Applicant address：

No. 157, Jinbi Road, Xishan District, Kunming City, Yunnan Province

Study leader's address：

No. 157, Jinbi Road, Xishan District, Kunming City, Yunnan Province

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：

云南省第一人民医院

Applicant's institution：

The First People's Hospital of Yunnan Province

研究负责人所在单位：

云南省第一人民医院

Affiliation of the Leader：

The First People's Hospital of Yunnan Province

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：

KHLL2025-KY214

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：

云南省第一人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First People's Hospital of Yunnan Province

伦理委员会批准日期：

Date of approved by ethic committee：

2024-07-25 00:00:00

伦理委员会联系人：

李丽

Contact Name of the ethic committee：

LiLi

伦理委员会联系地址：

云南省昆明市西山区金碧路157号

Contact Address of the ethic committee：

No. 157, Jinbi Road, Xishan District, Kunming City, Yunnan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 151 9895 8356

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：

云南省第一人民医院

Primary sponsor：

The First People's Hospital of Yunnan Province

研究实施负责（组长）单位地址：

云南省昆明市西山区金碧路157号

Primary sponsor's address：

No. 157, Jinbi Road, Xishan District, Kunming City, Yunnan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

云南

市(区县)：

Country：

China

Province：

YunNan

City：

单位(医院)：

云南省第一人民医院

具体地址：

云南省昆明市西山区金碧路157号

Institution
hospital：

The First People's Hospital of Yunnan Province

Address：

No. 157, Jinbi Road, Xishan District, Kunming City, Yunnan Province

经费或物资来源：

云南省科技计划重大专项

Source(s) of funding：

Major Special Projects of Science and Technology Planning in Yunnan Province

Target disease：

Infertility

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）揭示辅助生殖人群特定病原微生物感染与助孕结局的相关性； （2）阐明针对性干预特定部位特定病原微生物对辅助生殖助孕结局的影响; （3）探讨典型病原微生物感染因素影响生育的机制； （4）研究与制定辅助生殖患者高危病原微生物感染标准化干预策略  

Objectives of Study：

(1) Revealing the association between specific pathogenic microbial infections in assisted reproductive individuals and the outcome of assisted reproduction; (2) Explaining the impact of targeted intervention on specific pathogenic microorganisms in specific areas on the outcome of assisted reproduction; (3) Exploring the mechanism by which typical pathogenic microbial infection factors affect fertility; (4) Exploring standardized intervention strategies for high-risk pathogenic microbial infections in assisted reproductive patients.

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.年龄为20-40岁； 2.不孕不育由不明原因或感染而导致； 3.自愿参与本研究项目并签署知情同意书。

Inclusion criteria

1. Age : 20 - 40 years old; 2. Infertility is caused by unknown reasons or infection; 3. Voluntarily participate in this research project and sign the informed consent form.

排除标准：

1.身体残疾/缺陷或患有重大疾病（如心脏病、肺结核和癌症等）; 2.由生长发育和遗传等先天因素或由环境危害等特发因素导致的不孕不育。

Exclusion criteria：

1. Physical disability/defect or suffering from serious diseases (such as heart disease, tuberculosis and cancer, etc.); 2. Infertility caused by congenital factors such as growth and development or by accidental factors such as environmental hazards.

研究实施时间：

Study execute time：

从 From 2025-07-25 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-11 00:00:00 至 To 2026-02-01 00:00:00  

干预措施：

Interventions：

组别：

不孕不育夫妇

样本量：

2000

Group：

Infertile couple

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

健康人群

样本量：

200

Group：

Healthy population

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南 

市(区县)：

  

Country：

China 

Province：

YunNan 

City：

 

单位(医院)：

云南省第一人民医院 

单位级别：

三甲 

Institution
hospital：

The First People's Hospital of Yunnan Province

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

临床妊娠率

指标类型：

主要指标

Outcome：

Clinical pregnancy rate

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：

阴道拭子

组织：

Sample Name：

Vaginal swab

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：

宫颈拭子

组织：

Sample Name：

Cervical swab

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：

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：

子宫内膜

组织：

Sample Name：

Endometrium

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 岁 years
最大 Max age 40 岁 years

性别：

男女均可

Gender：

Both

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：

Blinding：

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）：

中国临床试验注册中心ResMan原始数据共享平台(IPD共享平台)

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

http://www.chictr.org.cn/index.aspx

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：

1数据采集管理 1.1数据库严格执行统一的数据库逻辑结构标准，统一的指标库标准，统一的数据模板标准。各组成员不得擅自在统一执行的表结构中增加、删除、修改相关字段；不得擅自增加、删除、修改指标库中的指标。 1.2各组人员认为数据库标准有错误或不合理的地方,应及时通知专管人员。相关信息化项目的数据库调整需经项目负责人审批通过后由技术人员统一处理。对于未信息化项目数据模版修改由项目负责人审批通过后,相关组别自行调整,调整后数据模版提交专管人员备案。 1.3专管人员统一下发数据库模板标准,数据库数据严格按模板标准采集。 1.4数据库数据源为信息化项目流程采集以及相关部门自行采集、定义。 1.5根据管理要求，各组别要求按时提交数据。 1.6各组别全面负责采集数据的质量。按模板格式采集数据后,方可录入数据库,操作人员负责一级审核，小组负责人负责二级复审。 1.7各组接到专管人员数据最终审核情况反馈后，若无差错则本月数据校验完成；若有错误，则重新采集、调整，重新采集、调整工作不得超过两个工作日。 2源数据及其文件的管理 2.1专管人员统一下发数据库数据处理平台，各项源数据处理需要在统一平台上进行。对于未信息化项目电子文档应存放于电子文档指定储存位置。 2.2根据数据管理要求,对主要服务器做实时备份,每半年做一次全备份,每个月做一次零级备份,每星期做一次一级备份,每天做一次二级备份,以保证数据库数据的安全。 2.3信息系统升级时,数据库以及电子文档将封存。在此期间封存数据以及电子文档调用需要通过专管人员及项目负责人审批后对申请人开放。 2.4定期对数据库所在的硬件及系统进行维护,保证数据库静态、动态及各类数据服务器、网站服务器的正常运行,定期检查病毒。 2.5后台专管人员对数据库进行动态监控和检查,发现问题应及时通知相关部门修正。 2.6负责数据库技术维护人员不得未经相关授权擅自以任何形式对外提供数据。如因管理、试验需要，可经技术负责人及项目负责人审批，通过的数据申请开通相关数据使用权限或提供相关数据服务。 2.7数据库文件使用人员可根据本人权限查询、使用数据库中的数据，当儿不得擅自对管理、试验无关人员提供数据服务。如有需要，必须经过小组负责人及项目负责人审批，通过的数据使用申请开通相关数据使用权限或提供相关数据服务。 3采集和录入（记录）人员管理 3.1专管人员负责数据库数据日常性监督,抽查入库数据的完整性、正确性、及时性,负责数据库采集与录入管理。 3.2技术人员承担数据库相关技术工作,负责系统软件、数据库软件的维护、日常的备份,培训辅导其他相关人员使用数据库。 3.3数据库实行专业负责制。专业责任人全面负责本组各专业的数据模版制作、数据釆集和日常的维护管理。小组内分工负责,责任到人。 3.4根据不同应用系统对数据库用户管理的要求，制定数据库用户管理制度和数据库操作规程，对各个应用系统的数据库的用户应有名单，不允许不同用户共享用户名或密码。 3.5根据系统管理员的授权，数据库用户分为系统管理员、应用查询人员、数据录入人员、系统维护人员。 3.6根据试验需要经项目负责人批准的用户权限级别可变更。特殊用户的权限设置应经流程审批。 3.7用户密码需通过复杂性检验，密码应定期更改，用户名及密码为个人专用，不得泄露给他人。特殊情况需他人以自己名义进入数据库时，应得到负责人同意，并在使用后 及时修改密码。 3.8使用者需遵守我方《信息保密制度》，未经许可不得向外界提供数据库中的相关数据，不得越权使用和修改数据。 4核对制度 4.1研究者作为一级审核人根据参试者的原始观察记录,保证将数据正确、完整、清晰、及时地载入病例报告表及试验记录表。 4.2监查人员作为二级审核人监查试验的进行是否遵循试验方案(如检查有无不符合入选排除标准的病例等)；对病例报告表进行核查，检查所填写的项目内容是否有误,并进行原始资料核对，确认所有病例报告表填写及录入正确完整,与原始资料一致，一旦发现问题及时纠正错误。 4.3监查员完成核查后将填写完整、准确的病例报告表及时送交数据专管人员进行最终审批。 4.4数据专管人员核查无误返给各组操作人员根据数据库标准模板，将正确的数据输入并整理，同时备份，以供校对分析。

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

1 data collection management 1.1 The database strictly implements the unified database logical structure standard, the unified index library standard, and the unified data template standard. Members of each group may not add, delete or modify related fields in the unified implementation of the table structure; the indicators in the indicator library shall not be added, deleted or modified without authorization. 1.2 If the personnel of each group believe that the database standard is wrong or unreasonable, the special personnel shall be notified in time. The database adjustment of related information projects shall be handled by the technical personnel after approval by the project leader. After the modification of the data template of the uninformed project is approved by the project leader, the relevant group will adjust it by itself, and the adjusted data template will be submitted to the special personnel for record. 1.3 The special management personnel uniformly issued the database template standard, and the database data was collected strictly according to the template standard. 1.4 Database data sources are collected and defined by the relevant departments. 1.5 According to management requirements, each group is required to submit data on time. 1.6 Each group is fully responsible for the quality of the collected data. After collecting data according to the template format, it can be entered into the database, the operator is responsible for the first-level review, and the team leader is responsible for the second-level review. 1.7 After receiving the feedback of the final audit data of the special personnel, each group will complete the data verification this month if there is no error; if there is an error, re-acquisition, adjustment, re-acquisition and adjustment work shall not exceed two working days. 2 source data and management of its files 2.1 The special management personnel shall issue the database data processing platform in a unified manner, and all source data processing needs to be carried out on a unified platform. For uninformed projects, electronic documents should be stored in the designated storage location of the electronic document. 2.2 According to the data management requirements, do real-time backup to the main server, do a full backup every six months, do a zero-level backup every month, do a level one backup every week, and do a second-level backup every day to ensure the security of the database data. . 2.3 When the information system is upgraded, the database and electronic documents will be archived. During this period, the sealed data and the electronic document call need to be open to the applicant after being approved by the special personnel and project leader. 2.4 Regularly maintain the hardware and system where the database is located to ensure the static and dynamic database and the normal operation of various data servers and web servers, and check the virus regularly. 2.5 The background special management personnel shall dynamically monitor and check the database, and notify the relevant departments to correct the problems if they are found. 2.6 Responsible for database technical maintenance personnel shall not provide data in any form without authorization. If it is required for management and testing, it can be approved by the technical person in charge and the person in charge of the project. The data submitted can be used to open relevant data usage rights or provide relevant data services. 2.7 Database file users can query and use the data in the database according to their own authority. When not allowed to provide data services to management and test-related personnel. If necessary, it must be approved by the team leader and project leader, and the data used to apply for the opening of relevant data usage rights or provide relevant data services. 3 collection and entry (recording) personnel management 3.1 Specialized personnel are responsible for the routine supervision of database data, check the integrity, correctness and timeliness of the inbound data, and be responsible for database collection and entry management. 3.2 The technical staff is responsible for database related technical work, responsible for system software, database software maintenance, daily backup, training and other related personnel to use the database. 3.3 The database implements a professional responsibility system. The professional responsible person is fully responsible for the data template production, data collection and daily maintenance management of each group. The division of labor within the group is responsible and the responsibility is to people. 3.4 According to the requirements of database management for different application systems, the database user management system and database operation procedures shall be formulated. Users of databases of each application system shall have a list, and different users are not allowed to share user names or passwords. 3.5 According to the authorization of the system administrator, the database users are divided into system administrators, application query personnel, data entry personnel, and system maintenance personnel. 3.6 The user privilege level approved by the project leader according to the test needs can be changed. The permission settings for special users should be approved by the process. 3.7 User passwords need to pass the complexity test. The passwords should be changed periodically. The user names and passwords are for personal use and should not be disclosed to others. In special circumstances, when someone needs to enter the database in their own name, they should get the consent of the responsible person and change the password in time after use. 3.8 Users are required to abide by our "Information Privacy System", and may not provide relevant data in the database to the outside world without permission, and may not use or modify the data beyond the authority. 4 check system 4.1 The researcher as the first-level auditor shall ensure that the data is correctly, completely, clearly and timely loaded into the case report form and the test record form based on the original observation records of the participants. 4.2 Whether the auditor as the second-level auditor conducts the test and complies with the test plan (such as checking whether there are any cases that do not meet the exclusion criteria); check the case report form to check whether the content of the completed project is incorrect, and Carry out the original data check, confirm that all the case report forms are filled in and entered correctly and consistently, consistent with the original data, and correct the errors in time if problems are found. 4.3 After the auditor completes the verification, the completed and accurate case report form will be sent to the data management personnel for final approval. 4.4 The data management personnel check and return to the operators of each group according to the database standard template, input and sort the correct data, and back up for proofreading analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-08-11 08:30:12