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一项随机对照试验比较卵巢低反应患者应用GnRH拮抗剂及安宫黄体酮抑制垂体早发LH峰的效果
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注册号:

Registration number:

ChiCTR-IPR-17010906 

最近更新日期:

Date of Last Refreshed on:

2019-03-21 

注册时间:

Date of Registration:

2017-03-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

一项随机对照试验比较卵巢低反应患者应用GnRH拮抗剂及安宫黄体酮抑制垂体早发LH峰的效果 

Public title:

The effects of preventing premature LH surge in ovarian poor responders using GnRH antagonist and MPA: a RCT 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卵巢低反应患者应用GnRH拮抗剂和安宫黄体酮抑制早发LH峰的效果 

Scientific title:

the comparison of GnRH antagonist and MPA in preventing premature LH surge in poor responders  

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:

陈秋菊 

研究负责人:

匡延平 

Applicant:

Chen Qiuju 

Study leader:

Kuang Yanping 

申请注册联系人电话:

Applicant telephone:

+86 021-53078108 

研究负责人电话:

Study leader's telephone:

+86 021-53078108 

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:

chenqj75@126.com 

研究负责人电子邮件:

Study leader's E-mail:

kuangyanp@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:

上海制造局路639号 

研究负责人通讯地址:

上海制造局路639号 

Applicant address:

639 Zhizaoju Road, Shanghai, China 

Study leader's address:

639 Zhizaoju 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:

 

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 

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:

2016--198-T142 

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伦理委员会 

Name of the ethic committee:

the Ethics Committee (Institutional Review Board) of the Shanghai Ninth People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-01-12 

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:

上海交通大学医学院附属第九人民医院 

Primary sponsor:

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

研究实施负责(组长)单位地址:

上海制造局路639号 

Primary sponsor's address:

639 Zhizaoju Road, Shanghai 

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):

Country:

China

Province:

Shanghai

City:

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:

制造局路639号

Institution
hospital:

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

Address:

639 Zhizaoju Road, Shanghai

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Nature Science Foundation of China 

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:

上市后药物 

Study phase:

研究目的:

通过随机对照试验比较卵巢低反应患者应用GnRH拮抗剂及安宫黄体酮抑制垂体早发LH峰的效果 

Objectives of Study:

To investigate the effect of GnRH antagonist and MPA in preventing premature LH surge in poor responders by a randomized controlled trial  

药物成份或治疗方案详述:

GnRH拮抗剂 (思泽凯) 安宫黄体酮 

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:

年龄22-42岁,有自发月经周期(21-35天),由于管性因素、男性因素、卵巢低储备、内异症或不明原因不孕进行IVF/ICSI的妇女,并符合Bologna卵巢低反应标准的不孕症妇女。Bologna标准为符合以下三条中的两条即可:1)年龄超过40岁或伴卵巢手术史;2)既往常规方案获卵数不超过3个;3)卵巢储备功能异常,包括双侧卵巢窦卵泡数AFC<7个,或AMH<1.1ng/ml。 

Inclusion criteria

1. Women who have a history of infertility ≥1 year 2. Women aged >22 and <42 years 3. Women with spontaneous menstrual cycles of 21–35 days 4. Women who have at least one of the following indications for IVF or ICSI: tubal factor, male factor, diminished ovarian reserve, endometriosis or unexplained factors 5. Women diagnosed as poor responders according to the Bologna criteria, including at least two of the three following criteria: (1) Advanced age (≥40 years) or any other risk factor for poor ovarian response; (2) A previous poor response with no more than three oocytes retrieved using the conventional stimulation protocols c. Abnormal ovarian reserve test results, including bilateral antral follicle counts <7 or serum antiMüllerian hormone <1.1 ng/ml. 

排除标准:

1.全身的系统性疾病如肾衰、系统性红斑狼疮等; 2. 卵巢早衰; 3.既往IVF已失败达到5次及以上者; 4 已知的苗勒氏管发育异常患者; 5. 合并超排卵的禁忌症如急性生殖道肿瘤、生殖道炎症等; 6. 不能依从研究方案者 

Exclusion criteria:

1. Clinically significant systemic diseases, such as renal failure and systemic lupus erythematosus; 2. Premature ovarian insufficiency; 3. Up to five previous unsuccessful IVF attempts; 4. Known Müllerian anomalies; 5. Any contraindications to ovarian stimulation treatments; 6. Unable to comply with the study procedures. 

研究实施时间:

Study execute time:

From2017-03-20To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2017-03-20To 2018-06-01 

干预措施:

Interventions:

组别:

GnRH拮抗剂

样本量:

170

Group:

GnRH antagonist

Sample size:

干预措施:

GnRH antagonist

干预措施代码:

Intervention:

GnRH antagonist

Intervention code:

组别:

安宫黄体酮

样本量:

170

Group:

MPA

Sample size:

干预措施:

MPA

干预措施代码:

Intervention:

MPA

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):

 

Country:

China 

Province:

Shanghai 

City:

 

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:

三级甲等医院 

Institution
hospital:

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

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

早发LH峰率

指标类型:

主要指标 

Outcome:

incidence of premature LH surge

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:

可用胚胎数

指标类型:

次要指标 

Outcome:

number of viable embryos

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

OHSS率

指标类型:

副作用指标 

Outcome:

incidence of OHSS

Type:

Adverse events 

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:

静脉血

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 25 years
最大 Max age 42 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):

统计专家通过计算机随机数字形成。

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

random number by computer

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):

是否共享原始数据:

IPD sharing

是Yes

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):

通过中国临床试验网数据平台共享

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

IPD will be shared by the platfrom of Chinese Clinical trial registery

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:

数据录入采用九院ART电子系统,生成EXCEL表格保存

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

data are managed by ART system and EXCEL system

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-03-18
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