今天是:2019-12-13 星期五

定坤丹对卵巢低反应患者IVF/ICSI-ET结局的影响:多中心随机对照试验
下载XML文档

注册号:

Registration number:

ChiCTR-IOR-17011697 

最近更新日期:

Date of Last Refreshed on:

2018-02-16 

注册时间:

Date of Registration:

2017-06-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

定坤丹对卵巢低反应患者IVF/ICSI-ET结局的影响:多中心随机对照试验 

Public title:

Efficacy and safety of traditional Chinese medicine (Ding-Kun-Dan) for infertility women with poor ovarian response (POR): multicenter, randomized controlled clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

定坤丹对卵巢低反应患者IVF/ICSI-ET结局的影响:多中心随机对照试验 

Scientific title:

Efficacy and safety of traditional Chinese medicine (Ding-Kun-Dan) for infertility women with poor ovarian response (POR): multicenter, randomized controlled clinical trial 

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:

韩靖佩 

研究负责人:

夏天 

Applicant:

Jingpei Han 

Study leader:

Tian Xia 

申请注册联系人电话:

Applicant telephone:

+86 18222799115 

研究负责人电话:

Study leader's telephone:

+86 15822238896 

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:

hanjp2012@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xiatian76@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:

天津市西青区昌凌路88号 

研究负责人通讯地址:

天津市西青区昌凌路88号 

Applicant address:

88 Changling Road, Xiqing District, Tianjin, China 

Study leader's address:

88 Changling Road, Xiqing District, Tianjin, 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:

天津中医药大学第一附属医院 

Applicant's institution:

The First Teaching Hospital of Tianjin University of Traditional Chinese 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:

TYLL2017[K]004 

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:

天津中医药大学第一附属医院医学伦理委员会 

Name of the ethic committee:

IEC of The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

天津中医药大学第一附属医院 

Primary sponsor:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine  

研究实施负责(组长)单位地址:

天津市西青区昌凌路88号 

Primary sponsor's address:

88 Changling Road, Xiqing District, Tianjin, 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):

天津市

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市西青区昌凌路88号

Institution
hospital:

The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Address:

88 Changling Road, Xiqing District, Tianjin, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-finance 

研究疾病:

卵巢低反应 

Target disease:

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:

其它 

Study phase:

N/A 

研究目的:

目的是评估定坤丹对卵巢低反应患者的疗效和安全性,以期为定坤丹改善POR患者行IVF/ICSI-ET结局提供临床证据,并为中医药在辅助生殖技术中的推广应用提供循证医学证据。 

Objectives of Study:

For assessing the efficacy and safety of Ding-Kun-Dan in the treatment of patients with POR. The results of this study will provide clinical evidence to evaluate the role of DKD treatment in women undergoing IVF/ICSI with POR. More importantly, it will be a new attempt of verifying the value of TCM in patients with POR in assisted reproductive technology.  

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.年龄介于25-38岁; 2.月经周期规律者(25-35天); 3.符合POR诊断标准者; 4.符合不孕症诊断标准者(若年龄<35岁,不孕时间≥1年者或年龄≥35岁,不孕时间≥6个月者或各种因素导致的配子运输障碍者,如输卵管梗阻、输卵管绝育术后等); 5.拟行IVF/ICSI-ET者; 6.自愿受试,并同意签署知情同意书的患者。 

Inclusion criteria

1. The patients aged 25 to 38 years old; 2. Regular menstrual cycle (25-35 days); 3. Patients who consistent with poor ovarian respond diagnosis ; 4. Patients who met the infertility criteria (if the age<35 years old, subfertility≥1 year; If the age ≥35 years old, subfertility≥6months. The infertility duration will not betaken into account if there is any causes to disorder the transport of the gamete, such as oviduct obstruction, after tubal sterilization, etc.); 5. Patients who prepare to receive IVF/ICSI; 6. Willing to accept the test and sign the informed consent. 

排除标准:

1.合并有其他内分泌疾病及自身免疫性疾病,如:多囊卵巢综合征、高泌乳素血症、高雄激素血症者、甲状腺功能异常、糖尿病; 2.合并有其他生殖系统疾病:如子宫内膜异位症、子宫内膜结核、宫腔粘连、子宫肌瘤(粘膜下肌瘤或非粘膜下肌瘤但肌瘤尺寸>4cm和/或子宫内膜受压者)、子宫畸形(双子宫、双角子宫、单角子宫、子宫纵膈等)、输卵管积水者; 3.合并内科、外科、精神科严重原发性疾病; 4.男方或女方合并有遗传或获得性疾病; 5.近三个月内服用过中药及激素类药物如避孕药、糖皮质激素等; 6.对研究方药中已知药物过敏者。 

Exclusion criteria:

1. With other endocrine diseases and autoimmune diseases, such as polycystic ovary syndrome, hyperlipidemia, Kaohsiung hormone, thyroid dysfunction, diabetes; 2. With other reproductive system diseases such as endometriosis, endometrial tuberculosis, intrauterine adhesions, uterine fibroids (submucous uterine myoma or not submucousmyoma but the diameter>4cm or oppress to endometrium), uterine malformation (uterus duplex, bicornuate uterus, unicornous uterus, septet uterus, etc.) hydrosalpinx; 3. With severe primary disease of internal medicine, surgery and psychiatric; 4. The female or her husband merged with genetic or acquired diseases; 5. Intake hormone drugs or Chinese herb (such as contraceptive drugs, ovulation-stimulating medicine, glucocorticoid etc) in 3 months prior to study entry; 6. Allergic to any ingredient within research drugs. 

研究实施时间:

Study execute time:

From2017-06-14To 2019-06-14 

干预措施:

Interventions:

组别:

试验组

样本量:

139

Group:

treatment group

Sample size:

干预措施:

口服定坤丹3个月

干预措施代码:

Intervention:

Oral Dingkun Dan for three months

Intervention code:

组别:

对照组

样本量:

139

Group:

control group

Sample size:

干预措施:

不予以干预措施

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

 

Country:

China 

Province:

Hebei 

City:

 

单位(医院):

河北医科大学第二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Second Affiliated Hospital of Hebei Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津医科大学总医院 

单位级别:

三级甲等医院 

Institution
hospital:

General Hospital of Tianjin Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第一中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Center Hospital of Tianjin  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

持续12周妊娠率

指标类型:

主要指标 

Outcome:

ongoing pregnancy 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:

试验组治疗前后抗苗勒管激素

指标类型:

次要指标 

Outcome:

the change of serum AMH level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促性腺激素用量

指标类型:

次要指标 

Outcome:

total gonadotropins dosage

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促性腺激素使用时间

指标类型:

次要指标 

Outcome:

duration of stimulation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

周期取消率

指标类型:

次要指标 

Outcome:

cycle cancellation rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

获卵数

指标类型:

次要指标 

Outcome:

the number of retrieved oocytes

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

优胚率

指标类型:

次要指标 

Outcome:

high qualified embryo rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化妊娠率

指标类型:

次要指标 

Outcome:

biochemical pregnancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

试验组治疗前后基础FSH水平

指标类型:

次要指标 

Outcome:

the change of serum FSH level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

试验组治疗前后基础窦卵泡数

指标类型:

次要指标 

Outcome:

the change of AFC

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

试验组治疗前后E2水平

指标类型:

次要指标 

Outcome:

the change of serum E2 level

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

hCG注射日雌激素(E2)、孕激素(P)水平

指标类型:

次要指标 

Outcome:

serum estradiol and progesterone level on the day of hCG administration

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 25 years
最大 Max age 40 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):

符合纳入标准的参加者将由天津康林德医药科技公司的统计人员独立进行随机分组,按照1:1比例随机分配给试验组或对照组。随机数将通过使用计算机动态随机化来生成。

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

The participants who meet the inclusion criteria will be randomly assigned to the experimental group or the controll group in a 1:1 ratio by central randomization performed by an independent statistician from Tianjin CLINDA Medical Technology Co.,Ltd. Random numbers will be generated by using dynamic randomiza

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

试验完成后6个月内,统计学结果需上传到临床试验公共管理平台ResMan

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

Within six months after the trial completed, the statistical results will be uploaded to the clinical trial public administration platform ResMan

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:

康林德电子数据采集系统

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

Electronic data capture of CLINDA

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-06-19
返回列表