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在激素替代周期中冻胚移植前黄体酮最佳持续使用时间
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注册号:

Registration number:

ChiCTR1900027941 

最近更新日期:

Date of Last Refreshed on:

2019-12-06 

注册时间:

Date of Registration:

2019-12-06 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

在激素替代周期中冻胚移植前黄体酮最佳持续使用时间 

Public title:

What is the optimal duration of progesterone supplementation before frozen embryo transfer in HRT cycles 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胞饮突检测改善子宫内膜容受性相关研究 

Scientific title:

Study for the improvement of endometrial receptivity by pinopode detection 

研究课题代号(代码):

Study subject ID:

浙江省医院卫生厅项目( 2018KY106) 

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:

赵莉娟 

研究负责人:

张松英 

Applicant:

Zhao Lijuan 

Study leader:

Zhang Songying 

申请注册联系人电话:

Applicant telephone:

+86 18758195289 

研究负责人电话:

Study leader's telephone:

+86 13805727588 

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:

zhaolijuan73455@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhangsongying@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:

浙江省杭州市庆春东路3号 

研究负责人通讯地址:

浙江省杭州市庆春东路3号 

Applicant address:

3 East Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

3 East Qingchun Road, Hangzhou, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

310016 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江大学医学院附属邵逸夫医院 

Applicant's institution:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang 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:

SRRSHRME2016002 

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邵逸夫医院生殖医学伦理委员会 

Name of the ethic committee:

Reproductive Medical Ethics Committee of Sir Run Run Shaw Hospital, College of Medicine,Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-07-06 

伦理委员会联系人:

俞云松 

Contact Name of the ethic committee:

Yu Yunsong 

伦理委员会联系地址:

浙江大学医学院附属邵逸夫医院 

Contact Address of the ethic committee:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 East Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属邵逸夫医院 

Primary sponsor:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市庆春东路3号 

Primary sponsor's address:

3 East 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邵逸夫医院

具体地址:

浙江省杭州市庆春东路3号

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Address:

3 East Qingchun Road, Hangzhou

经费或物资来源:

浙江省医院卫生厅项目( 2018KY106) 

Source(s) of funding:

the general project of medicine and health in Zhejiang Province of China (2018KY106) 

研究疾病:

胚胎反复种植失败 

Target disease:

Repeated embryo implantation failure 

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:

探索性研究/预试验 

Study phase:

研究目的:

在激素替代-冻胚移植周期中黄体酮分别连续使用3天与4天临床妊娠率的比较 

Objectives of Study:

The comparison of clinical pregnancy rates of progesterone administration continuously for 3 days and 4 days in HRT-FET cycle 

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:

a.年龄<35周岁; b.因单纯输卵管因素、男性因素、PCO因素不孕的患者; c.本中心首次取卵并且既往未曾移植的患者, 优胚个数大于等于4个,; 

Inclusion criteria

1. aged < 35 years; 2. infertility due to simple fallopian tube factor, male factor and PCO factor; 3. the patients who have egg retrievals for the first time in our center and have not been transplanted before ;the number of good embryos is more than or equal to 4; 4. remove the deformity of internal and external genitalia, hydrosalpinx, and organic diseases of uterus, such as adenomyosis or hysteromyoma. 

排除标准:

排除内外生殖器畸形、输卵管积水,子宫器质性疾病如合并腺肌症或子宫肌瘤等。 

Exclusion criteria:

Remove the deformity of internal and external genitalia, hydrosalpinx, and organic diseases of uterus, such as adenomyosis or hysteromyoma 

研究实施时间:

Study execute time:

From2018-07-01To 2020-01-01 

干预措施:

Interventions:

组别:

P+3 组

样本量:

50

Group:

P+3

Sample size:

干预措施:

HRT周期孕酮作用3天后移植2个D3 优胚

干预措施代码:

Intervention:

Two D3 embryos were transplanted after 3 days of progesterone treatment in HRT cycle

Intervention code:

组别:

P+4 组

样本量:

50

Group:

P+4

Sample size:

干预措施:

HRT 周期孕酮作用4天后移植2个D3优胚

干预措施代码:

Intervention:

Two D3 embryos were transplanted after 4 days of progesterone treatment in HRT cycle

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):

浙大学医学院附属邵逸夫医院 

单位级别:

三甲附属医院 

Institution
hospital:

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University  

Level of the institution:

Tertiary A Hospital 

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:

指标中文名:

子宫内膜容受性标志物

指标类型:

主要指标 

Outcome:

the marker of endometrial receptivity

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:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

简单随机分组法 1.事先拟定100个研究对象序号 2.产生随机数字(随机数字表法) 3.规定随机数字为奇数的研究对象分到 P+3组,偶数分到P+4组 4.保留随机分配方案的文件

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

The researchers used simple randomization: 1. Prepare the serial numbers of 100 subjects in advance; 2. Generate random numbers (random number table method); 3. Subjects whose random numbers are specified as odd are divided into groups P + 3 and even into groups P + 4; 4. Keep the documents of r

盲法:

Open label

Blinding:

Open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

论文支持材料; ResMan

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

surpporting materials for the artical; 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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-06
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