今天是:2018-01-19 星期五

低LH患者PPOS促排卵方案加用克罗米芬的疗效评估
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注册号:

Registration number:

ChiCTR1800014440 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

低LH患者PPOS促排卵方案加用克罗米芬的疗效评估 

Public title:

The effect of PPOS+Clomiphene Citrate protocal for IVF-ET therapy in patients with low basal LH  

研究课题的正式科学名称:

低LH患者PPOS促排卵方案加用克罗米芬的疗效评估 

Scientific title:

The effect of PPOS+Clomiphene Citrate protocal for IVF-ET therapy in patients with low basal LH  

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:

芦雪峰 

研究负责人:

芦雪峰 

Applicant:

Xuefeng Lu 

Study leader:

Xuefeng Lu 

申请注册联系人电话:

Applicant telephone:

+86 1564597129 

研究负责人电话:

Study leader's telephone:

+86 13564597129 

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:

xuefenglu163@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xuefenglu163@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:

上海市制造局路639号 

研究负责人通讯地址:

上海市制造局路639号 

Applicant address:

639 Zhizhaoju Road, Shanghai, China 

Study leader's address:

639 Zhizhaoju Road, Shanghai, 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:

200001 

申请人所在单位:

上海交通大学医学院附属第九人民医院 

Applicant's institution:

Shanghai Ninth People's Hospital, Shanghai Jiaotong 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:

2017-416-T312 

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:

上海交通大学医学院附属第九人民医院医学伦理委员会 

Name of the ethic committee:

Scientific Research Projects Approval Determination of Independent Ethics Committee of Shanghai Ninth People's Hospital aaffiliated to Shanghai JiaoTong University, School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-11-10 

伦理委员会联系人:

罗蒙 

Contact Name of the ethic committee:

Meng Luo 

伦理委员会联系地址:

上海市制造局路639号 

Contact Address of the ethic committee:

639 Zhizhaoju Road, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-23271699-5576 

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:

上海交通大学医学院附属第九人民医院 

Primary sponsor:

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine 

研究实施负责(组长)单位地址:

上海市制造局路639号 

Primary sponsor's address:

639 Zhizhaoju Road, Shanghai, 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):

上海

市(区县):

上海

Country:

China

Province:

Shanghai

City:

Shanghai

单位(医院):

上海交通大学医学院附属第九人民医院

具体地址:

上海市制造局路639号

Institution
hospital:

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Address:

639 Zhizhaoju Road, Shanghai, China

经费或物资来源:

上海交通大学医学院附属第九人民医院 

Source(s) of funding:

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

基础LH低下的不孕症患者因LH处于低水平不利于卵泡的生长发育,并且垂体反应低下,导致取卵率下降,降低了IVF的成功率。本研究旨在分析研究基础LH处于较低水平(LH<2.27mIU/ml)的患者应用PPOS方案时加用CC是否可以提高获卵率、获卵数及胚胎质量,并增加IVF妊娠率。 

Objectives of Study:

As Patients with low LH level had suboptimal response to GnRH agonist trigger and had lower rate of oocyte retrieval. The objectives of this study is to evaluate the effect of PPOS+Clomiphene Citrate used for controlled ovarian stimulation in patients with lower LH level compared with PPOS protocol. 

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)根据我们之前的报道:月经第三天基础LH<2.27mIU/ml不孕症患者; 2)女性年龄小于38岁; 3)BMI<23; 4)基础FSH<10mIU/ml。  

Inclusion criteria

1. Basal serum LH level<2.27mIU/ml; 2. Age<38 years old; 3. BMI<23; 4. Basal FSH level<10mIU/ml.  

排除标准:

1)全身系统性疾病不宜妊娠的患者; 2)子宫内膜异位症患者; 3)卵巢早衰患者; 4)低促性腺激素性性功能减退; 5)生殖道肿瘤的患者; 6)近3个月接受激素替代治疗的患者的患者。  

Exclusion criteria:

1) Clinical significant systemic disease; 2) Endometriosis; 3) patients documented ovarian failure; 4) Idiopathie hypogonadotropoc hypogonadism; 5) Patients with genital tract tumors; 6) Patients recieve hormone treatments within the previous 3 month period.  

研究实施时间:

Study execute time:

From2017-12-01To 2020-07-01 

干预措施:

Interventions:

组别:

PPOS /PPOS+CC

样本量:

230

Group:

PPOS /PPOS+CC

Sample size:

干预措施:

PPOS方案基础上加用克罗米芬

干预措施代码:

Intervention:

PPOS+ Clomiphene Citrate

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

上海交通大学医学院附属第九人民医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

获卵率

指标类型:

主要指标 

Outcome:

Oocyte retrieval 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:

获卵率

指标类型:

主要指标 

Outcome:

Oocyte retrieval 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:

获卵率

指标类型:

主要指标 

Outcome:

Oocyte retrieval 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:

获卵率

指标类型:

主要指标 

Outcome:

Oocyte retrieval 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:

获卵率

指标类型:

主要指标 

Outcome:

Oocyte retrieval 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:

获卵率

指标类型:

主要指标 

Outcome:

Oocyte retrieval 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:

获卵数

指标类型:

次要指标 

Outcome:

Number of oocyte retrieved

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

获得胚胎数

指标类型:

次要指标 

Outcome:

Embryos frozen

Type:

Secondary 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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 38 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):

用SSPS软件产生随机号,随机分组

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

Generate Random Numbers using SSPS software

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):

2020年12月通过网络平台公布, MedRis, http://ssoapp.2m9h.net:8087/home

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

We will share our data in Dec. 2020 through MedRis system (http://ssoapp.2m9h.net:8087/home)

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:

病例记录表及电子病历系统(MedRis)

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

Case Record Form and MedRis system

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-13
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