今天是:2017-12-19 星期二

催产素对男性性取向影响的研究
下载XML文档

注册号:

Registration number:

ChiCTR-IOR-17011402 

最近更新日期:

Date of Last Refreshed on:

2017-06-01 

注册时间:

Date of Registration:

2017-05-14 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

催产素对男性性取向影响的研究 

Public title:

A study on the effect of oxytocin on sexual orientation in men 

研究课题的正式科学名称:

催产素对男性性取向影响的研究 

Scientific title:

A study on the effect of oxytocin on sexual orientation in men 

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:

胡少华 

研究负责人:

胡少华 

Applicant:

Shaohua Hu 

Study leader:

Shaohua Hu 

申请注册联系人电话:

Applicant telephone:

+86 571 56723001 

研究负责人电话:

Study leader's telephone:

+86 571 56723001 

申请注册联系人传真 :

Applicant Fax:

+86 571 56723001 

研究负责人传真:

Study leader's fax:

86-571-56723001 

申请注册联系人电子邮件:

Applicant E-mail:

dorhushaohua@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

dorhushaohua@zju.edu.cn 

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:

浙江省杭州市庆春路79号 

研究负责人通讯地址:

浙江省杭州市庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310003 

研究负责人邮政编码:

Study leader's postcode:

310003 

申请人所在单位:

浙江大学医学院附属第一医院 

Applicant's institution:

First Affiliated Hospital, Zhejiang University School of Medicine 

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:

2015-2 

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:

浙江大学医学院附属第一医院科研伦理审查委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University  

伦理委员会批准日期:

Date of approved by ethic committee:

2015-01-13 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

浙江大学医学院附属第一医院 

Primary sponsor:

First Affiliated Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

Hangzhou

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市庆春路79号

Institution
hospital:

First Affiliated Hospital, Zhejiang University School of Medicine

Address:

79 Qingchun Road, Hangzhou, Zhejiang, China

经费或物资来源:

浙江省科技厅公益项目 

Source(s) of funding:

the public welfare project of Science Technology Department of Zhejiang Province 

研究疾病:

基础研究 

Target disease:

Basical study 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

研究男性同性恋大脑活动以及社会性别认知的特点以及催产素对它们的影响。 

Objectives of Study:

This study aims to research the feature of brain activity and social gender cognition in male homosexuals, and how oxytocin affects them. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1)完全的男同性恋(金赛量表得分=6),年龄在18-40岁之间;2)没有躯体和精神方面的疾病;3)无长期用药史或药物依赖;4)没有催产素的禁忌症;5)视力或矫正视力达0.8;6)双眼无散光或已校正;7)注意力能够正常集中;8)完全右利手;9)没有金属植入物或者心脏起搏器;10)完全志愿参加;11)受试者及其家属或法定监护人签署书面知情同意书,一式两份。 

Inclusion criteria

1) Complete male homosexuality (the Kinsey Scale score= 6), aged 18-40 years old; 2) No physical disease or mental disorder; 3) No long-term medication or drug dependence; 4) No contraindication of oxytocin; 5) The visual acuity or corrected visual acuity reached 0.8; 6) No astigmia of either eye or the astigmia had been corrected; 7) The attention is normal; 8) Right handed completely; 9) No metallic implants or pacemaker (such as metallic artificial limb, metallic artificial teeth, cardiac pacemaker, etc.); 10) Completely voluntary participation; 11) Written informed consents in duplicate were obtained from the family members or the guardians or the statutory agents of all the participants. 

排除标准:

1)色盲;2)鼻炎或鼻窦炎; 3)既往有哮喘或过敏史;4)患有精神疾病,例如精神分裂症,双相情感障碍;5)消极观念或自杀倾向;6)最近一周失眠;7)最近一周吸烟;8)(曾)患有神经系统疾病,例如癫痫、脑外伤、脑炎、脑膜炎、三叉神经痛等;9)(曾)患有内分泌系统疾病,如糖尿病、库欣综合征、甲状腺功能亢进、甲状腺功能减退、高泌乳素血症等;10)其他躯体疾病,例如高血压、心脏病、肾病、肝病等;11)过去3个月曾有药物治疗史。 

Exclusion criteria:

1) Color blindness; 2) Rhinitis or nasosinusitis; 3) Asthma or anaphylaxis; 4) Mental disorders, such as schizophrenia, bipolar disorder, etc.; 5) Hold negtive thoughts or suicide tendency; 6) Insomnia in the past week; 7) Smoking in the past week; 8) Suffering or suffered nervous system diseases, such as epilepsy, cerebral trauma, encephalitis, cephalomeningitis, prosopalgia, etc.; 9) Suffering or suffered endocrine system diseases, such as diabetes mellitus, Cushing's syndrome, hyperthyroidism, hypothyroidism, hyperprolactinemia, etc.; 10) Other physical diseases, such as hypertension, heart disease, nephropathy, hepatic disfunction, etc.; 11) Medication history in the past 3 months.  

研究实施时间:

Study execute time:

From2015-10-01To 2017-12-31 

干预措施:

Interventions:

组别:

实验组

样本量:

10

Group:

experimental group

Sample size:

干预措施:

鼻喷催产素24IU,每隔1min左右鼻孔各喷1IU

干预措施代码:

Intervention:

24IU oxytocin sprayed intrnasally, 1IU oxytocin is sprayed every 1 min in both nares

Intervention code:

组别:

对照组

样本量:

10

Group:

control group

Sample size:

干预措施:

鼻喷生理盐水2.4ml,每隔1min左右鼻孔各喷0.1ml

干预措施代码:

Intervention:

2.4ml normal saline sprayed intrnasally, 0.1ml normal saline is sprayed every 1 min in both nares

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

金赛量表得分

指标类型:

主要指标 

Outcome:

the score of Kinsey Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Klein量表得分

指标类型:

主要指标 

Outcome:

the score of Klein scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性别认知测试数据

指标类型:

主要指标 

Outcome:

the data of Gender cognitive tests

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头颅功能磁共振影像

指标类型:

主要指标 

Outcome:

the functional magnetic resonance imaging of brain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

副作用指标 

Outcome:

blood pressure

Type:

Adverse events 

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:

没有

组织:

Sample Name:

None

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

随机数表法,由我科胡健波产生

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

random number table produced by Jianbo Hu

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

共享日期为本研究完成论文发表后,共享方式可以是上传数据库ResMan

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

We will share the IPD after the research paper is published by uploading database ResMan

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:

采用SPSS保存和搜集数据库。

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

We manage the data with SPSS.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-05-14
返回列表