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The relationship between luteal phase endometrial transformation and pinopode and its effect on pregnancy outcome
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注册号:

Registration number:

ChiCTR-OOC-17012214 

最近更新日期:

Date of Last Refreshed on:

2017-08-01 

注册时间:

Date of Registration:

2017-08-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

黄体期子宫内膜转化与胞饮突表达相关性及其对妊娠结局的影响 

Public title:

The relationship between luteal phase endometrial transformation and pinopode and its effect on pregnancy outcome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

黄体期子宫内膜转化与胞饮突表达相关性及其对妊娠结局的影响 

Scientific title:

The relationship between luteal phase endometrial transformation and pinopode and its effect on pregnancy outcome 

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:

侯昭娟 

研究负责人:

李艳萍 

Applicant:

Zhaojuan Hou 

Study leader:

Yanping Li 

申请注册联系人电话:

Applicant telephone:

+86 15898586052 

研究负责人电话:

Study leader's telephone:

+86 13607317798 

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:

1412301501@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

lisayanping@sina.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:

湖南省长沙市开福区湘雅路87号湘雅医院 

研究负责人通讯地址:

湖南省长沙市开福区湘雅路87号湘雅医院 

Applicant address:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, China 

Study leader's address:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, 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:

中南大学湘雅医院 

Applicant's institution:

Xiangya Hospital of Central South 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:

2017001 

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:

中南大学湘雅医院生殖医学中心医学伦理委员会 

Name of the ethic committee:

Ethics committee of Reproductive Medicine Center of Xiangya Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-07-25 

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:

湘雅医院生殖医学中心 

Primary sponsor:

Reproductive Medicine Center of Xiangya Hospital  

研究实施负责(组长)单位地址:

中国湖南省长沙市湘雅路87号 

Primary sponsor's address:

87 Xiangya Road, Kaifu District, Changsha, Hu'nan, 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):

湖南

市(区县):

长沙市

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湘雅医院生殖医学中心

具体地址:

湖南省长沙市湘雅路87号

Institution
hospital:

Reproductive medicine center of xiangya hospital

Address:

87 Xiangya Road, Changsha, Hunan

经费或物资来源:

湘雅医院临床科研基金 

Source(s) of funding:

Clinical research fund of Xiangya hospital  

研究疾病:

不孕症 

Target disease:

infertility 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

(1)研究内膜转化率与妊娠结局的关系; (2)探索B超能否作为一种简单无创的手段来预测种植窗的开启。 

Objectives of Study:

(1) To study the relationship between endometrial transformation rate and pregnancy outcome; (2) To investigate whether B-ultrasound can be a simple and noninvasive mean to predict implantation window. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

(1)年龄20-37周岁的女性 (2)18.5≤BMI<25 (3)有正常月经周期且自发排卵的女性 (4)卵巢储备功能良好 (5)至少有两个可移植的优质胚胎(优质胚胎定义为第3天发育到6~10个卵裂球的Ⅰ、Ⅱ级胚胎) 

Inclusion criteria

(1) the female aged between 22 to 35 years old; (2) body mass index (BMI) ranged from 18.5 to 25; (3) normal menstrual cycle with spontaneous ovulation; (4) normal ovarian reserve; (5) at least two high-grade embryos. 

排除标准:

(1)有多囊卵巢综合征、子宫内膜异位症、糖尿病、甲亢、甲减等影响妊娠或妊娠结局的疾病 (2)存在已知的内膜息肉、宫腔粘连或黏膜下肌瘤 (3)HCG日孕酮浓度≥1.5ng/ml的患者 (4)OHSS倾向。 

Exclusion criteria:

(1) any negative factors affecting embryo implantation, such as:polycystic ovarian syndrome(PCOS), uterine adhesion, severe hydrosalpinx, advanced endometriosis of stage III to IV, myoma adenomyosis and adenomyoma adjacent to uterine cavity, unresponsive thin endometrium; (2) serum progesterone level on human chronic gonadotrophin(HCG) day was more than 1.5ng/ml; (3) the tedency of ovarian hyperstimulation syndrome(OHSS). 

研究实施时间:

Study execute time:

From2017-08-07To  

干预措施:

Interventions:

组别:

Case series

样本量:

120

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hu'nan 

City:

Changsha City 

单位(医院):

湘雅医院 

单位级别:

附属医院 

Institution
hospital:

Xiangya hospital  

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:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

子宫内膜

组织:

子宫

Sample Name:

endometrium

Tissue:

Uterine

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 20 years
最大 Max age 37 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):

N/A

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

N/A

盲法:

Blinding:

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:

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):

中南大学湘雅医院

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

Xiangya Hospital Central-south University

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:

中南大学湘雅医院

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

Xiangya Hospital Central-south University

数据管理委员会:

Data Managemen Committee:

注册人:

Name of Registration:

 2017-08-01
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