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Study for Yimaxin for luteal phase support in assisted reproduction
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注册号:

Registration number:

ChiCTR1900027963 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

益玛欣用于辅助生殖中黄体支持的研究 

Public title:

Study for Yimaxin for luteal phase support in assisted reproduction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

益玛欣用于辅助生殖中黄体支持的研究 

Scientific title:

Study for Yimaxin for luteal phase support in assisted reproduction 

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:

高金梅 

研究负责人:

赵君利 

Applicant:

Jinmei Gao 

Study leader:

Junli Zhao 

申请注册联系人电话:

Applicant telephone:

+86 18408611911 

研究负责人电话:

Study leader's telephone:

+86 13909519609 

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:

1143603496@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

zhaojunli6812@163.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:

宁夏医科大学双怡校区 

研究负责人通讯地址:

宁夏回族自治区银川市兴庆区胜利街1160号 

Applicant address:

Shuangyi campus of Ningxia Medical university  

Study leader's address:

1160 Shengli Street, Xingqing District, Yinchuan, Ningxia Hui Autonomous Region, 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:

宁夏医科大学 

Applicant's institution:

Ningxia Medical university  

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:

2019-476 

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:

宁夏医科大学总医院医学科研伦理审查委员会 

Name of the ethic committee:

The Medical Research Ethics Review of Ningxia Medical genral hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

魏洁 

Contact Name of the ethic committee:

Jie Wei 

伦理委员会联系地址:

宁夏医科大学总医院科研处 

Contact Address of the ethic committee:

Department of Research Project Administration, The General Hospital of Ningxia Medical University, 1160 Shengli Street, Xingqing District, Yinchuan, Ningxia Hui Autonomous Region, China 

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:

宁夏医科大学总医院 

Primary sponsor:

Ningxia Medical Genral Hospital 

研究实施负责(组长)单位地址:

宁夏回族自治区银川市兴庆区胜利街1160号 

Primary sponsor's address:

1160 Shengli Street, Xingqing District, Yinchuan, Ningxia Hui Autonomous Region, 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):

宁夏回族自治区

市(区县):

Country:

China

Province:

Ningxia Hui Autonomous Region

City:

单位(医院):

宁夏医科大学总医院

具体地址:

银川市兴庆区胜利街1160号

Institution
hospital:

Ningxia Medical Genral Hospital

Address:

1160 Shengli Street, Xingqing District, Yinchuan

经费或物资来源:

自费 

Source(s) of funding:

Self 

研究疾病:

女性不孕 

Target disease:

Fmale infertility 

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:

上市后药物 

Study phase:

研究目的:

比较益玛欣、地屈孕酮、雪诺酮用于冻胚移植黄体支持的优缺点 

Objectives of Study:

To compare the advantages and disadvantages of yimaxin dydrogesterone,and crinone for frozen embryo luteal phase support 

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 

Study design:

Parallel 

纳入标准:

1.患者年龄20~40岁 2.FSH<15IU/L 3.BMI<25 

Inclusion criteria

1. Patient 20-40 years; 2. FSH<15IU/L; 3. BMI<25. 

排除标准:

1.既往未获得临床妊娠的移植次数≥3次 2.合并宫腔异常者 3.复发性流产患者 4.甲功、肝功异常、高泌乳素血症,既往神经系统疾病,高血压患者 5.对研究药物过敏患者 6.双方中任一方染色体异常者 

Exclusion criteria:

1.>=3 transplants without previous clinical pregnancy; 2. Patient with uterine cavity abnormalities; 3. Patient with recurrent miscarriage; 4. Abnormal liver or thyroid function or hyperlactinemia or with past neurological disorder hypertension; 5. People allergic to research drugs; 6. A people with chromosomal abnormality on both side. 

研究实施时间:

Study execute time:

From2019-12-04To 2020-03-01 

干预措施:

Interventions:

组别:

有排卵周期组

样本量:

50

Group:

Ovulation cycle group

Sample size:

干预措施:

A1 地屈孕酮10mg/bid +A2 益玛欣100mg/bid +A3 益玛欣100mg/tid

干预措施代码:

Intervention:

A1 Dydrogesterone10mg/bid +A2 Yimaxin100mg/bid +A3 Yimaxin100mg/tid

Intervention code:

组别:

无排卵周期组

样本量:

50

Group:

Anovulation cycle Group

Sample size:

干预措施:

B1 雪诺酮90mg/qd +B2 益玛欣100mg/tid +B3 益玛欣200mg/bid

干预措施代码:

Intervention:

B1 crinone90mg/qd + B2 Yimaxin100mg/tid + B3 Yimaxin200mg/bid

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

宁夏回族自治区 

市(区县):

 

Country:

China 

Province:

Ningxia Hui Autonomous Region 

City:

 

单位(医院):

宁夏医科大学总医院 

单位级别:

三级甲等医院 

Institution
hospital:

Ningxia Medical genral hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

妊娠

指标类型:

主要指标 

Outcome:

Pregnancy

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:

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 years
最大 Max age 40 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由研究者采用随机数字法

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

By the researchers using the random number method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

未确定

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

Not yet

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:

未确定

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

Not yet

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-12-07
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