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FSH刺激周期添加芳香化酶抑制剂:降低卵巢刺激对内膜影响研究方案
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注册号:

Registration number:

ChiCTR-IPR-15006211 

最近更新日期:

Date of Last Refreshed on:

2015-04-08 

注册时间:

Date of Registration:

2015-04-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

FSH刺激周期添加芳香化酶抑制剂:降低卵巢刺激对内膜影响研究方案 

Public title:

A study of adding aromatase inhibitors in the FSH stimulation cycle to reduce the impact of ovarian stimulation on the endometrium 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卵泡生成素(FSH)刺激周期添加芳香化酶抑制剂:降低卵巢刺激对内膜的影响研究方案 

Scientific title:

A study of adding aromatase inhibitors in the follicle stimulating hormone (FSH) stimulation cycle to reduce the impact of ovarian stimulation on the endometrium 

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:

杨晓祎 

研究负责人:

龚斐 

Applicant:

Yang xiaoyi 

Study leader:

Gong Fei 

申请注册联系人电话:

Applicant telephone:

+86 13574103823 

研究负责人电话:

Study leader's telephone:

+86 13907485296 

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:

shelly_333@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

lj_0305@126.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:

中国湖南省长沙市湘雅路84号 

研究负责人通讯地址:

中国湖南省长沙市湘雅路84号 

Applicant address:

84 Xiangya Road, Changsha, Hunan, China 

Study leader's address:

84 Xiangya Road, Changsha, Hunan, China 

申请注册联系人邮政编码:

Applicant postcode:

410078 

研究负责人邮政编码:

Study leader's postcode:

410078 

申请人所在单位:

中信湘雅生殖与遗传专科医院 

Applicant's institution:

Reproductive & Genetic Hospital CITIC-XIANGYA 

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:

LL-SC-SG-2014-014 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中信湘雅生殖与遗传专科医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Reproductive & Genetic Hospital CITIC-XIANGYA 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-11-20 

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:

中信湘雅生殖与遗传专科医院 

Primary sponsor:

Reproductive & Genetic Hospital CITIC-XIANGYA 

研究实施负责(组长)单位地址:

中国湖南省长沙市湘雅路84号 

Primary sponsor's address:

84 Xiangya Road, Changsha, Hunan, 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):

Country:

China

Province:

Hunan

City:

单位(医院):

中信湘雅生殖与遗传专科医院

具体地址:

中国湖南省长沙市湘雅路84号

Institution
hospital:

Reproductive & Genetic Hospital CITIC-XIANGYA

Address:

84 Xiangya Road, Changsha, Hunan, China

经费或物资来源:

中信湘雅生殖与遗传专科医院 

Source(s) of funding:

Reproductive & Genetic Hospital CITIC-XIANGYA 

研究疾病:

不孕症 

Target disease:

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:

探索性研究/预试验 

Study phase:

研究目的:

在本研究中希望研究来曲唑辅助治疗是否能够降低卵泡晚期的雌二醇超生理水平与降低卵泡晚期孕激素过早的上升;以及积极影响子宫内膜容受性,提高胚胎着床率 

Objectives of Study:

In this reseach, we want to know added letrozole in the treatment can reduce the super physiological levels of estradiol and reduce premature progesterone rise in the late follicular cycle; a positive impact on endometrial receptivity and improve embryo implantation rate. 

药物成份或治疗方案详述:

来曲唑 

Description for medicine or protocol of treatment in detail:

letrozole 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

21≤ 年龄≤35岁,18≤BMI ≤28,第一或者第二治疗周期, 基础 FSH <8miu/ml,AMH >1ng/l,窦卵泡数(AFC )15-23 

Inclusion criteria

Female to be aged 21 to 35 years, BMI 18 to 28, the first or the second treatment cycle; Basis FSH <8miu/ml, AMH>1ng/l, antral follicle count (AFC) 15-23. 

排除标准:

子宫内膜异位性疾病、单侧或者双侧输卵管积水未阻断、子宫畸形、子宫黏膜下肌瘤、子宫肌壁间肌瘤>3cm, 宫腔粘连,不明原因宫腔积液,既往有过不明原因流产史,IVF治疗禁忌症 

Exclusion criteria:

Endometriosis disease, unilateral or bilateral hydrosalpinx not blocked, uterine malformations, uterine fibroids submucosal, intramural uterine fibroids >3cm, intrauterine adhesions, unexplained uterine fluid, a history of unexplained miscarriages, the contraindications of IVF treatment 

研究实施时间:

Study execute time:

From2015-05-01To 2015-11-30 

干预措施:

Interventions:

组别:

A组

样本量:

65

Group:

A

Sample size:

干预措施:

卵巢刺激第五天开始,同时辅助使用芳香化酶抑制剂来曲唑2.5mg/每天,直到注射HCG日

干预措施代码:

Intervention:

The fifth day in Ovarian stimulation, add letrozole 2.5mg / day until the day of HCG injection

Intervention code:

组别:

B组

样本量:

65

Group:

B

Sample size:

干预措施:

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 

市(区县):

 

Country:

China 

Province:

Hunan 

City:

 

单位(医院):

中信湘雅生殖与遗传专科医院 

单位级别:

民营医院 

Institution
hospital:

Reproductive & Genetic Hospital CITIC-XIANGYA  

Level of the institution:

Private hospital 

测量指标:

Outcomes:

指标中文名:

HCG注射日血清孕激素(P)水平

指标类型:

主要指标 

Outcome:

progesterone (P) levels in HCG injection day

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

HCG注射日孕激素/雌激素比值(P/E2比值)

指标类型:

主要指标 

Outcome:

Progestin / estrogen ratio (P / E2 ratio) in HCG injection day

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 21 years
最大 Max age 35 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):

计算机软件

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

computer generation

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-04-07
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