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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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: |
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申请人所在单位: |
山东大学附属生殖医院 |
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Applicant's institution: |
Center for Reproductive Medicine, Shandong University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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 |
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Name of the ethic committee: |
Institutional Review Board of Center for Reproductive Medicine, Shandong University |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
Center for Reproductive Medicine, Shandong University |
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研究实施负责(组长)单位地址: |
山东省济南市经六路157号 |
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Primary sponsor's address: |
157 Jingliu Road, Jinan, Shandong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
无 |
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Source(s) of funding: |
Nil |
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研究疾病: |
不孕症,卵巢低反应 |
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Target disease: |
Infertility, poor ovarian response |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
Study phase: |
4 |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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 |
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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. |
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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。 |
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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: |
从From2015-09-01至To 2017-10-31 |
征募观察对象时间: Recruiting time: |
从From2015-09-01至To 2016-10-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
女性 |
Gender: |
Female |
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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 |
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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: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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): |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
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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: |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |