基于PI3K/AKT/mTOR通路探讨益肾通络方影响精索静脉曲张不育患者曲张静脉内皮细胞调亡的机制

注册号:

Registration number:

ITMCTR2200005640

最近更新日期:

Date of Last Refreshed on:

2022-02-15

注册时间:

Date of Registration:

2022-02-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于PI3K/AKT/mTOR通路探讨益肾通络方影响精索静脉曲张不育患者曲张静脉内皮细胞调亡的机制

Public title:

To explore the mechanism of Yishen Tongluo formula affecting the apoptosis of varicocele vein endothelial cells in varicocele infertility patients based on PI3K/AKT/mTOR pathway

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于PI3K/AKT/mTOR通路探讨益肾通络方影响精索静脉曲张不育患者曲张静脉内皮细胞调亡的机制

Scientific title:

To explore the mechanism of Yishen Tongluo formula affecting the apoptosis of varicocele vein endothelial cells in varicocele infertility patients based on PI3K/AKT/mTOR pathway

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:

ChiCTR2200056766 ; ChiMCTR2200005640

申请注册联系人:

张宸铭

研究负责人:

李勋

Applicant:

Chenming Zhang

Study leader:

Xun Li

申请注册联系人电话:

Applicant telephone:

18768887043

研究负责人电话:

Study leader's telephone:

13803814345

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:

zcmhnzy@163.com

研究负责人电子邮件:

Study leader's E-mail:

hnzzzym@163.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:

中国河南省郑州市金水区东风路6号

研究负责人通讯地址:

中国河南省郑州市金水区东风路6号

Applicant address:

No. 6, Dongfeng Road, Jinshui District, Zhengzhou City, Henan Province, China

Study leader's address:

No. 6, Dongfeng Road, Jinshui District, Zhengzhou City, Henan Province, 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:

河南省中医院(河南中医药大学第二附属医院)

Applicant's institution:

Henan Province Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Henan University of Chinese Medicine)

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:

医院伦理审第(1214-01)号

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

河南省中医院(河南中医药大学第二附属医院)伦理委员会

Name of the ethic committee:

The Ethics Committee of Henan Province Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Henan University of Chinese Medicine)

伦理委员会批准日期:

Date of approved by ethic committee:

2021/7/9 0:00:00

伦理委员会联系人:

赵彩燕

Contact Name of the ethic committee:

Caiyan Zhao

伦理委员会联系地址:

河南省郑州市金水区东风路6号

Contact Address of the ethic committee:

No. 6, Dongfeng Road, Jinshui District, Zhengzhou, Henan, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

0371-60903768

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zcaiy0928@163.com

研究实施负责(组长)单位:

河南省中医院(河南中医药大学第二附属医院)

Primary sponsor:

Henan Province Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Henan University of Chinese Medicine)

研究实施负责(组长)单位地址:

中国河南省郑州市金水区东风路6号

Primary sponsor's address:

No. 6, Dongfeng Road, Jinshui District, Zhengzhou, Henan, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

China

Province:

Henan

City:

zhengzhou

单位(医院):

河南省中医院(河南中医药大学第二附属医院)

具体地址:

中国河南省郑州市金水区东风路6号

Institution
hospital:

Henan Province Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Henan University of Chinese Medicine)

Address:

No. 6, Dongfeng Road, Jinshui District, Zhengzhou, Henan, China

经费或物资来源:

2017年度河南省中医药科学研究专项课题,项目编号2017ZY2066; 2018年度河南省高等学校重点科研项目,项目编号18A320002; 2021年度河南省中医药科学研究专项课题,项目编号20-21ZY2060; 国家自然科学基金(编号:81974573) 国家自然科学基金(编号:81573981)

Source(s) of funding:

2017 Henan Province Traditional Chinese Medicine Scientific Research Special Project, project number 2017ZY2066;Key scientific research projects of higher education institutions in Henan Province in 2

研究疾病:

精索静脉曲张

研究疾病代码:

Target disease:

Varicocele

Target disease code:

研究类型:

Study type:

治疗研究

Treatment study

研究设计:

Study design:

单臂

Single arm

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

为了探索益肾通络方治疗精索静脉曲张性不育的机制

Objectives of Study:

To explore the mechanism of Yishen Tongluo formula in the treatment of varicocele infertility.

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符合2015年精索静脉曲张诊断与治疗中国专家共识[1],且具备以下其中一种情况; ②存在不育;精液质量异常;女方生育能力正常,或虽患有引起不孕的相关疾病,但可能治愈; ③虽暂无生育要求,但检查发现精液质量异常者; ④精索静脉曲张所伴发的相关症状(如会阴部或睾丸的坠胀、疼痛等)较严重,明显影响生活质量,经保守治疗改善不明显; ⑤Ⅱ度或Ⅲ度精索静脉曲张,血清睾酮水平明显下降,排除其他疾病所致者。 参考文献[1]:邓春华, 商学军. 精索静脉曲张诊断与治疗中国专家共识. 中华男科学杂志. 2015;21(11):1035-42.

Inclusion criteria

①In line with the 2015 Chinese expert consensus on the diagnosis and treatment of varicocele [1], and one of the following conditions; ②infertility;abnormal semen quality;The woman has normal fertility, or has a related disease that causes infertility but may be cured; ③Abnormal semen quality is found by examination,although there is no requirement for fertility; ④The related symptoms associated with varicocele (such as perineal or testicular bulging pain, etc.) are more serious and significantly affect the quality of life,and the conservative treatment does not improve significantly ⑤The serum testosterone level of grade Ⅱ or Ⅲ varicocele decreased significantly excluding other diseases References[1]:Chun-Hua Deng,Xue-Jun Shang.Chinese expert consensus on the diagnosis and treatment of varicocele.Zhonghua Nan Ke Xue.2015;21(11):1035-42.

排除标准:

①继发性精索静脉曲张,包括左侧肾静脉胡桃夹综合征,腹腔、腹膜后肿瘤压迫等原因; ②合并严重肝肾功能不全、高血压、糖尿病、凝血功能异常等; ③既往有精索静脉手术史且术后复发; ④无精子症; ⑤合并先天性发育异常、遗传性疾病或精神病、神经系统疾病; ⑥逆行射精、勃起功能障碍、睾丸萎缩。

Exclusion criteria:

①Secondary varicocele, including left renal vein nutcracker syndrome, abdominal and retroperitoneal tumor compression and other causes; ②Combined with severe liver and kidney insufficiency, hypertension, diabetes, abnormal coagulation function, etc; ③Combined with previous history of spermatic vein surgery and postoperative recurrence; ④Combined with Azoospermia ⑤Combined with congenital developmental abnormalities, genetic or psychiatric disorders, neurological disorders; ⑥Combined with retrograde ejaculation, erectile dysfunction, testicular atrophy.

研究实施时间:

Study execute time:

From 2021-07-01

To      2024-07-01

征募观察对象时间:

Recruiting time:

From 2022-03-01

To      2023-07-01

干预措施:

Interventions:

组别:

单臂研究,不适用

样本量:

60

Group:

experimental group

Sample size:

干预措施:

益肾通络方干预曲张的精索静脉

干预措施代码:

Intervention:

Yishen Tongluo Formula on Varicose spermatic vein

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

China

Province:

Henan province

City:

Zhengzhou

单位(医院):

河南省中医院(河南中医药大学第二附属医院)

单位级别:

省级医院

Institution/hospital:

Henan Province Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Henan University of Chinese Medicine)

Level of the institution:

Provincial Hospital

测量指标:

Outcomes:

指标中文名:

全外显子检测技术(WES)检测精索静脉曲张患者突变基因

指标类型:

主要指标

Outcome:

Whole exome testing(WES) was used to detect mutated genes in patients with varicocele

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

曲张静脉内皮细胞转录组测序及qRT-PCR验证

指标类型:

主要指标

Outcome:

RNA-seq on varicose vein endothelial cells followed by qRT-PCR verification

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

曲张静脉内皮细胞中cyclinD2、PCNA、caspase-3、survivin蛋白表达

指标类型:

主要指标

Outcome:

Expression of cyclinD2, PCNA, caspase-3 and survivin protein in varicose vein endothelial cells

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

曲张静脉内皮细胞中p-PI3K、p-AKT、p-mTOR、 Beclin1、IGF-1蛋白表达

指标类型:

主要指标

Outcome:

Expression of p-PI3K, p-AKT, p-mTOR, Beclin1, IGF-1 protein in varicose vein endothelial cells

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:

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:

标本中文名:

精索静脉

组织:

Sample Name:

spermatic vein

Tissue:

人体标本去向

使用后保存

说明

保存1年用于细胞培养研究

Fate of sample 

Preservation after use

Note:

Keep for 1 year for cell culture study

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 25
Min age years
最大 35
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

本研究所有标本采集自精索静脉曲张患者,属于单臂研究,自身对照,无需进行随机分组

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

In this study, all specimens were collected from patients with varicocele, and it is a single-arm, self-control study that doesn't have to do random grouping

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

科研论文发表之后,联系研究者电子邮件获取

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

After the publication of research papers,Obtained by email from the researcher

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:

数据采集和管理采用病例记录表

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

A CRF will be used for data collection and management

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):

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