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卵巢低反应患者体外受精助孕前给予DHEA治疗12周是否改善活产率
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注册号:

Registration number:

ChiCTR-IPR-15006909 

最近更新日期:

Date of Last Refreshed on:

2015-11-10 

注册时间:

Date of Registration:

2015-08-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

卵巢低反应患者体外受精助孕前给予DHEA治疗12周是否改善活产率 

Public title:

Does DHEA treatment for 12 weeks before in-vitro fertilization improve the live birth rate in poor ovarian responder? 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卵巢低反应患者体外受精助孕前给予DHEA治疗12周是否改善活产率 

Scientific title:

Does DHEA treatment for 12 weeks before in-vitro fertilization improve the live birth rate in poor ovarian responder? 

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:

秦莹莹 

研究负责人:

陈子江 

Applicant:

Yingying Qin 

Study leader:

Zi-Jiang Chen 

申请注册联系人电话:

Applicant telephone:

+86 18668952167 

研究负责人电话:

Study leader's telephone:

+86 0531-85651189 

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:

qinyingying1006@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenzijiang@vip.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:

山东省济南市经六路157号 

研究负责人通讯地址:

山东省济南市经六路157号 

Applicant address:

157 Jingliu Road, Jinan, Shandong, China 

Study leader's address:

157 Jingliu Road, Jinan, Shandong, 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:

山东大学附属生殖医院 

Applicant's institution:

Center for Reproductive Medicine, Shandong 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:

2015伦审字(20)号 

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:

山东大学附属生殖医院伦理委员会 

Name of the ethic committee:

Institutional Review Board of Center for Reproductive Medicine, Shandong University 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-08-10 

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:

山东大学附属生殖医院 

Primary sponsor:

Center for Reproductive Medicine, Shandong University 

研究实施负责(组长)单位地址:

山东省济南市经六路157号 

Primary sponsor's address:

157 Jingliu Road, Jinan, Shandong, 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):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东大学附属生殖医院

具体地址:

山东省济南市经六路157号

Institution
hospital:

Center for Reproductive Medicine, Shandong University

Address:

157 Jingliu Road, Jinan, Shandong, China

经费或物资来源:

无 

Source(s) of funding:

Nil 

研究疾病:

不孕症,卵巢低反应 

Target disease:

Infertility, poor ovarian response 

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:

本研究拟采用随机双盲对照的方法,在卵巢低反应患者(bologna标准)中体外受精-胚胎移植助孕前开始给予DHEA 75mg/d,给药12周,评价与安慰剂比较,其对活产率的改善作用。 

Objectives of Study:

This is a placebo controlled randomized clinical trial aiming to evaluate the effect of DHEA 75mg/d pretreatment for 12 weeks before in-vitro fertilization on the live birth rate in patients with poor ovarian response. 

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:

1. 不孕时间≥1年; 2. 月经规律者,定义为月经周期≥21天且≤35天; 3. 卵巢低反应患者,按照Bologna共识中对卵巢低反应的定义 

Inclusion criteria

1. women who had tried to become pregnant for at least 1 year; 2. women with regular menses defined as the length of cycle 21~35 days; 3. women diagnosed with poor ovarian response according to Bologna consensus. 

排除标准:

1. 既往3次以上非自然周期取卵周期未获得临床妊娠者; 2. 未经治疗的子宫畸形或异常:双子宫、纵隔子宫(完全或不完全);宫腔粘连、子宫腺肌症、黏膜下子宫肌瘤、子宫内膜息肉; 3. 未经治疗的一侧或两侧输卵管积水(子宫输卵管造影检查证实) 4. 既往2次及以上自然流产史者(不包括生化妊娠流产); 5. 夫妇双方中任一方染色体核型异常者; 6. 曾接受过细胞毒性药物化疗者; 7. 曾接受过盆腔放疗者; 8. 既往曾服用DHEA等雄激素制剂者; 9. 有癫痫病史者; 10. 对DHEA过敏者; 11. 正在应用胰岛素治疗者(由于胰岛素可降低DHEA水平从而影响DHEA的效果) 12. 合并辅助生殖技术或妊娠禁忌症,如未控制的肝肾功能异常、糖尿病、高血压、甲状腺疾病、症状性心脏病、中重度贫血及恶性肿瘤病史或血栓性疾病史。 

Exclusion criteria:

1. women who had failed in 3 or more IVF cycle with ovarian stimulation and oocyte pickup; 2. women diagnosed with uterine malformation or abnormality; 3. women diagnosed with hydrosalpinx in hysterosalpingography; 4. women who had a history of spontaneous miscarriage for 2 times or more (biochemical miscarriage does not count in); 5. couples with female or male abnormal karyotype; 6. women who had undergone chemotherapy with cytotoxic agents; 7. women who had undergone pelvic radiotherapy; 8. women who had taken DHEA before enrollment; 9. women with a history of epilepsy; 10. women who is allergic to DHEA; 11. women who is using insulin; 12. women with contraindications to assisted reproductive technology or pregnancy. 

研究实施时间:

Study execute time:

From2015-09-01To 2017-10-31 

征募观察对象时间:

Recruiting time:

From2015-09-01To 2016-10-31 

干预措施:

Interventions:

组别:

DHEA组

样本量:

355

Group:

DHEA group

Sample size:

干预措施:

DHEA 3#/d 12周

干预措施代码:

Intervention:

DHEA 3 tablets daily for 12 weeks

Intervention code:

组别:

安慰剂组

样本量:

355

Group:

Placebo group

Sample size:

干预措施:

安慰剂 3#/d 12周

干预措施代码:

Intervention:

Placebo 3 tablets daily for 12 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东大学附属生殖医院 

单位级别:

国家辅助生殖技术研究中心 

Institution
hospital:

Center for Reproductive Medicine, Shandong University  

Level of the institution:

National research center of ART 

国家:

中国 

省(直辖市):

山东 

市(区县):

青岛 

Country:

China 

Province:

Shandong 

City:

Qingdao 

单位(医院):

青岛大学医学院附属医院 

单位级别:

三级甲等医院 

Institution
hospital:

Affiliated hospital of medical college of Qingdao Universiry  

Level of the institution:

tertiary hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

烟台 

Country:

China 

Province:

Shandong 

City:

Yantai 

单位(医院):

烟台毓璜顶医院 

单位级别:

三级甲等医院 

Institution
hospital:

Yuhuangding Hospital  

Level of the institution:

tertiary hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

青岛 

Country:

China 

Province:

Shandong 

City:

Qingdao 

单位(医院):

青岛市妇女儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Qingdao women and chidren's hospital  

Level of the institution:

tertiary 

国家:

中国 

省(直辖市):

山东 

市(区县):

潍坊 

Country:

China 

Province:

Shandong 

City:

Weifang 

单位(医院):

潍坊医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated hospital of Weifang medical college  

Level of the institution:

tertiary hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

济宁 

Country:

China 

Province:

Shandong 

City:

Jining 

单位(医院):

济宁医学院附属医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated hospital of Jining medical college  

Level of the institution:

tertiary hospital 

测量指标:

Outcomes:

指标中文名:

活产率

指标类型:

主要指标 

Outcome:

Live biirth 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:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 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):

在线中央随机;分层区组随机

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

online central randomization system with stratified block random method

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

否No

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:

 2015-08-10
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