The mechanism of icariin regulating TWEAK/SIRT1 and promoting Shelterin complex mediated telomere protection in thin endometrium

注册号:

Registration number:

ITMCTR2025000203

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

淫羊藿苷调节TWEAK/SIRT1而促进Shelterin复合物介导的端粒保护在薄型子宫内膜中的作用机制

Public title:

The mechanism of icariin regulating TWEAK/SIRT1 and promoting Shelterin complex mediated telomere protection in thin endometrium

注册题目简写:

English Acronym:

研究课题的正式科学名称:

淫羊藿苷调节TWEAK/SIRT1而促进Shelterin复合物介导的端粒保护在薄型子宫内膜中的作用机制

Scientific title:

The mechanism of icariin regulating TWEAK/SIRT1 and promoting Shelterin complex mediated telomere protection in thin endometrium

研究课题的正式科学名称简写:

Scientific title acronym:

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:

乐爱文

研究负责人:

乐爱文

Applicant:

Le ai wen

Study leader:

Le ai wen

申请注册联系人电话:

Applicant telephone:

+8618038090785

研究负责人电话:

Study leader's telephone:

+8618038090785

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:

leaiwen@126.com

研究负责人电子邮件:

Study leader's E-mail:

leaiwen@126.com

申请单位网址(自愿提供):

Study leader's 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:

深圳市南山区桃园路89号

研究负责人通讯地址:

深圳市南山区桃园路89号

Applicant address:

89 Taoyuan Road, Nanshan District, Shenzhen

Study leader's address:

89 Taoyuan Road, Nanshan District, Shenzhen

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:

深圳市南山区人民医院

Applicant's institution:

shenzhen nanshan people hospital' hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

ky-2024-042401

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

华中科技大学协和深圳医院

Name of the ethic committee:

Huazhong University of Science and Technology Union Shenzhen Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/31 0:00:00

伦理委员会联系人:

黄晓佳

Contact Name of the ethic committee:

Huang Xiaojia

伦理委员会联系地址:

深圳市南山区桃园路89号

Contact Address of the ethic committee:

89 Taoyuan Road, Nanshan District, Shenzhen

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 180 3809 0785

伦理委员会联系人邮箱:

Contact email of the ethic committee:

leaiwen362531@126.com

研究实施负责(组长)单位:

深圳市南山区人民医院

Primary sponsor:

shenzhen nanshan people hospital' hospital

研究实施负责(组长)单位地址:

深圳市南山区桃园路89号

Primary sponsor's address:

89 Taoyuan Road, Nanshan District, Shenzhen

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

市(区县):

深圳市

Country:

China

Province:

guandong

City:

shenzhen

单位(医院):

深圳市南山区人民医院

具体地址:

深圳市南山区桃园路89号

Institution
hospital:

shenzhen nanshan people hospital' hospital

Address:

89 Taoyuan Road, Nanshan District, Shenzhen

经费或物资来源:

深圳市南山区科技局课题

Source(s) of funding:

Project of Nanshan District Science and Technology Bureau, Shenzhen

研究疾病:

薄型子宫内膜

研究疾病代码:

Target disease:

Thin endometrium

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

病例对照研究

Case-Control study

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

明确NFE2L2、TWEAK、SIRT1、Shelterin复合物表达水平、端粒长度及衰老细胞数目与TE的相关性;探究淫羊藿苷通过激活转录因子NFE2L2上调TWEAK/SIRT1而促进Shelterin复合物介导端粒保护在治疗TE中的作用机制。

Objectives of Study:

Clarify the correlation between the expression levels of NFE2L2, TWEAK, SIRT1, Shelterin complex, telomere length, and aging cell number with TE; Exploring the mechanism of icariin promoting Shelterin complex mediated telomere protection in the treatment of TE by activating transcription factor NFE2L2 and upregulating TWEAK/SIRT1.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

A 经量少于30 ml(根据月经失血图法); B 已经第2-5天性激素水平检测在正常范围; C 宫腔镜检查:月经第15-25天(月经周期25-30天)子宫内膜光滑菲薄,宫腔无粘连,输卵管开口清晰可见; D 经阴道彩色多普勒超声(TV-CDU)子宫内膜厚度测量:分泌期子宫内膜厚度<7 mm; 正常子宫内膜:经量少于30 ml,子宫内膜厚度≥7 mm,余同上。

Inclusion criteria

A menstrual flow less than 30 ml (according to menstrual bleeding chart method); B sex hormone levels were within normal range on the 2nd to 5th day of testing; C Hysteroscopy examination: On the 15th to 25th day of menstruation (25th to 30th day of menstrual cycle), the endometrium is smooth and thin, there is no adhesion.In the uterine cavity, and the opening of the fallopian tubes is clearly visible; Normal endometrium: Menstrual volume less than 30 ml, endometrial thickness ≥ 7 mm, and the rests are the same as above. D Measurement of endometrial thickness using transvaginal color Doppler ultrasound (TV-CDU): endometrial thickness during secretion phase<7 mm;

排除标准:

未签署知情同意的患者;内科疾患如糖尿病、结核病以及甲状腺、肾上腺等内分泌疾病;严重感染性疾病或脏器疾病;肿瘤等可能造成系统影响的疾病。

Exclusion criteria:

Patients who have not signed informed consent; Internal diseases such as diabetes, tuberculosis, thyroid, adrenal and other endocrine diseases; Serious infectious diseases or organ disease; Diseases such as tumors that may cause systemic effects.

研究实施时间:

Study execute time:

From 2024-12-20

To      2026-07-31

征募观察对象时间:

Recruiting time:

From 2025-01-28

To      2025-07-31

干预措施:

Interventions:

组别:

正常子宫内膜组

样本量:

10

Group:

Normal endometrium group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

组别:

薄型子宫内膜组

样本量:

10

Group:

thin endometrium group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

样本总量 Total sample size : 20

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

guandong

City:

单位(医院):

深圳市南山区人民医院

单位级别:

三甲

Institution/hospital:

shenzhen nanshan people hospital' hospital

Level of the institution:

Class A tertiary hospital

测量指标:

Outcomes:

指标中文名:

肿瘤坏死因子样弱凋亡诱导因子(TWEAK) 表达

指标类型:

主要指标

Outcome:

Expression of tumor necrosis factor-like weak inducer of apoptosis

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Shelterin复合物表达

指标类型:

主要指标

Outcome:

Expression of Shelterin complex

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

细胞衰老相关蛋白1(SIRT1)表达

指标类型:

主要指标

Outcome:

Expression of Sirtuin 1

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

端粒长度

指标类型:

次要指标

Outcome:

telomere length

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

核转录因子E2相关因子2(NFE2L2)表达

指标类型:

主要指标

Outcome:

Expression of nuclear factor erythroid 2-like-2

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:

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 45
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

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

None

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):

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

none

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:

医院信息管理系统(HIS)和Excel软件管理数据

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

Hospital Information System and Excel software manages data

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above