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Clinical study of the treatment of infertility caused by severe intrauterine adhesions by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem cells
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注册号:

Registration number:

ChiCTR-OPC-14005553 

最近更新日期:

Date of Last Refreshed on:

2018-07-22 

注册时间:

Date of Registration:

2014-11-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胶原膜复合脐带间充质干细胞治疗严重宫腔粘连所致不孕症的临床研究 

Public title:

Clinical study of the treatment of infertility caused by severe intrauterine adhesions by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem cells 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胶原膜复合脐带间充质干细胞治疗严重宫腔粘连所致不孕症的临床研究 

Scientific title:

Clinical study of the treatment of infertility caused by severe intrauterine adhesions by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem cells 

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:

李新安 

研究负责人:

胡娅莉 

Applicant:

Xin-an Li 

Study leader:

Yali Hu 

申请注册联系人电话:

Applicant telephone:

+86 15905197916 

研究负责人电话:

Study leader's telephone:

+86 13951846008 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 13951846008 

申请注册联系人电子邮件:

Applicant E-mail:

li_xinan@126.com 

研究负责人电子邮件:

Study leader's E-mail:

glyyhuyali@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.njglyy.com/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.njglyy.com/ 

申请注册联系人通讯地址:

江苏省南京市中山路321号南京鼓楼医院妇产科 

研究负责人通讯地址:

江苏省南京市中山路321号南京鼓楼医院妇产科 

Applicant address:

Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, 321 Zhongshan Road, Nanjing, Jiangsu, China 

Study leader's address:

Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, 321 Zhongshan Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210008 

研究负责人邮政编码:

Study leader's postcode:

210008 

申请人所在单位:

南京大学医学院附属鼓楼医院 

Applicant's institution:

The Affiliated Drum Tower Hospital of Nanjing University Medical School 

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:

2014-065-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南京大学医学院附属鼓楼医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-11-25 

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:

南京大学医学院附属鼓楼医院 

Primary sponsor:

The Affiliated Drum Tower Hospital of Nanjing University Medical School 

研究实施负责(组长)单位地址:

江苏省南京市中山路321号南京鼓楼医院妇产科 

Primary sponsor's address:

Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital, 321 Zhongshan Road, Nanjing, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京大学医学院附属鼓楼医院

具体地址:

江苏省南京市中山路321号南京鼓楼医院妇产科

Institution
hospital:

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Address:

Department of Obstetrics and Gynecology, Nanjing Drum Tower Hospital ,321, Zhongshan Road, Nanjing, Jiangsu, China

经费或物资来源:

中国科学院战略性先导科技专项 

Source(s) of funding:

Strategic Priority Research Program of Chinese Academy of Science 

研究疾病:

严重子宫宫腔粘连所致不孕症 

Target disease:

infertility caused by severe intrauterine adhesions 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

研究胶原膜复合脐带间充质干细胞治疗严重宫腔粘连、子宫内膜瘢痕化所致不孕症,为子宫性不孕症的治疗提供新方法。 

Objectives of Study:

Study of the treatment of infertility caused by severe intrauterine adhesions or endometrial dysplasia by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem cells, and to provide clinical evidence for the treatment of uterine infertility. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1、药物及手术干预无效的严重宫腔粘连或子宫内膜瘢痕化患者; 2、年龄:22-45岁; 3、愿意接受随访者。 

Inclusion criteria

1. patients with severe intrauterine adhesions or scarring of the endometrium for whom drugs and surgical interventions were ineffective; 2. Age: 22-45 years old; 3. who is willing to accept follow-up. 

排除标准:

1、染色体核型异常; 2、有严重的子宫内膜异位症; 3、子宫腺肌症; 4、严重的先天性子宫畸形; 5、阴道炎及子宫内膜炎; 6、全身性疾病:高血压、糖尿病等; 7、有妊娠禁忌症; 8、激素替代治疗禁忌症; 9、既往盆腔肿瘤病史或接受放疗后; 10、无法坚持到院检查及随访,或随访期间欲行其他治疗。 

Exclusion criteria:

1. Chromosome karyotype abnormalities; 2. Severe endometriosis; 3. Severe adenomyosis; 4. Severe congenital uterine malformations; 5. Vaginitis and endometritis; 6. systemic diseases: hypertension, diabetes, and so on; 7. Contraindications to pregnancy; 8. Contraindications to hormone replacement therapy; 9. Medical history of pelvic tumors or receiving pelvic radiotherapy; 10. Unable to adhere to the hospital examination and follow-up, or carrying on other treatment during follow-up period. 

研究实施时间:

Study execute time:

From2014-11-07To 2016-11-01 

干预措施:

Interventions:

组别:

干预组

样本量:

20

Group:

collagen scaffold loaded with umbilical cord blood

Sample size:

干预措施:

宫腔镜粘连分解后胶原膜复合脐带间充质干细胞治疗

干预措施代码:

Intervention:

hysteroscopy adhesiolysis followed by collagen scaffold loaded with umbilical cord blood-derived mesenchymal stem cells treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京大学医学院附属鼓楼医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Drum Tower Hospital of Nanjing University Medical School  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

月经情况

指标类型:

主要指标 

Outcome:

Menstruation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫内膜厚度及血供

指标类型:

主要指标 

Outcome:

Endometrial thickness and blood flow

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫内膜生长状况

指标类型:

主要指标 

Outcome:

Endometrial recovery status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

受孕情况

指标类型:

主要指标 

Outcome:

Conception

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

产前检查情况

指标类型:

次要指标 

Outcome:

Prenatal care

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:

宫腔内容物

组织:

胎盘

Sample Name:

Uterine contents

Tissue:

Placenta

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 45 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):

N/A

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

N/A

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

南京大学医学院附属鼓楼医院

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

The Affiliated Drum Tower Hospital of Nanjing University Medical School

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:

南京大学医学院附属鼓楼医院

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

The Affiliated Drum Tower Hospital of Nanjing University Medical School

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-11-28
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