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生长激素伴随用药对于改善胚胎质量差患者临床结局的应用研究
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注册号:

Registration number:

ChiCTR1900021992 

最近更新日期:

Date of Last Refreshed on:

2019-03-19 

注册时间:

Date of Registration:

2019-03-19 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

生长激素伴随用药对于改善胚胎质量差患者临床结局的应用研究 

Public title:

Tth hormone supplementation on the clinical outcomes in patients with poor-quality embryo 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

生长激素伴随用药对于改善辅助生殖中胚胎发育差患者临床结局的应用研究 

Scientific title:

The effect of growth hormone supplementation on the clinical outcomes in IVF patients with poor embryonic development 

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:

李竞宇 

研究负责人:

叶虹 

Applicant:

Jingyu Li 

Study leader:

Hong Ye 

申请注册联系人电话:

Applicant telephone:

+86 13908368839 

研究负责人电话:

Study leader's telephone:

+86 023-63839850 

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:

tnljy@126.com 

研究负责人电子邮件:

Study leader's E-mail:

cqtnljy@gmail.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:

重庆市渝中区金汤街64号 

研究负责人通讯地址:

重庆市渝中区金汤街64号 

Applicant address:

64 Jintang Street, Yuzhong District, Chongqing, China 

Study leader's address:

64 Jintang Street, Yuzhong District, Chongqing, 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:

重庆市妇幼保健院 

Applicant's institution:

Chongqing Health Center for Women and Children 

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:

2018-RGI-04 

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:

重庆市妇幼保健院伦理委员会 

Name of the ethic committee:

Ethics Committee of Chongqing Maternal and Child Health Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

冯泽水 

Contact Name of the ethic committee:

Feng Zheshui 

伦理委员会联系地址:

重庆市渝中区金汤街64号 

Contact Address of the ethic committee:

64 Jintang Street, Yuzhong District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23 63316835 

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:

重庆市妇幼保健院 

Primary sponsor:

Chongqing Health Center for Women and Children 

研究实施负责(组长)单位地址:

重庆市渝中区金汤街64号 

Primary sponsor's address:

64 Jintang Street, Yuzhong District, Chongqing, 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):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市妇幼保健院

具体地址:

重庆市渝中区金汤街64号

Institution
hospital:

Chongqing Health Center for Women and Children

Address:

64 Jintang Street, Yuzhong District, Chongqing, China

经费或物资来源:

重庆市科学技术委员会 

Source(s) of funding:

Chongqing Science and Technology Commission 

研究疾病:

不孕不育 

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:

探索性研究/预试验 

Study phase:

研究目的:

1.探索生长激素对卵子质量和临床妊娠率的影响; 2.通过分析生长激素组和对照组卵子颗粒细胞线粒体的DNA拷贝数,初步明确生长激素改善妇女卵子质量的分子机制. 

Objectives of Study:

1. To explore the effect of supplementation of growth hormone on improving the oocyte quality and clinical pregancy; 2. To explore the mechanism of the improvement by adjuvant GH therapy, we compared oocyte quality between patients with or without GH treatment through calculating mitochondrial DNA (mtDNA) content of cumulus granulosa cells (CGCs).  

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 < 45岁; 2.利用IVF或ICSI助孕; 3.前次周期失败,主要原因为胚胎质量差(无 Ⅰ-Ⅱ级胚胎); 4.排卵正常、子宫正常。 

Inclusion criteria

1. Aged <45 years; 2. undergo cycle of IVF or ICSI; 3. Previous failure mainly because of low quality of oocyte (no grade I or II); 4. Normal ovulation and uterus. 

排除标准:

1.内分泌疾病及子宫内膜异位; 2.微刺激方案; 3.自然周期助孕; 4.PGD/PGS; 5.男性不育因素; 6.生长激素禁忌证患者。 

Exclusion criteria:

1. Endocrine diseases and endometriosis; 2. Mini-stimulation; 3. Natural assisted pregnancy. 4. PGD/PGS 5. Male factor; 6. Contraindication of growth hormone. 

研究实施时间:

Study execute time:

From2017-07-01To 2019-02-01 

干预措施:

Interventions:

组别:

生长激素

样本量:

107

Group:

Group 1

Sample size:

干预措施:

生长激素伴随用药

干预措施代码:

Intervention:

Growth hormone supplement

Intervention code:

组别:

非生长激素

样本量:

51

Group:

Group 2

Sample size:

干预措施:

常规卵巢刺激

干预措施代码:

Intervention:

normal controlled ovarian stimulation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市妇幼保健院 

单位级别:

三级甲等医院 

Institution
hospital:

Chongqing Health Center for Women and Children  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

着床率

指标类型:

主要指标 

Outcome:

implantation 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:

临床妊娠率

指标类型:

主要指标 

Outcome:

clinical 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:

获卵数

指标类型:

主要指标 

Outcome:

number of oocytes retrieved

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

受精率

指标类型:

主要指标 

Outcome:

fertlization 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:

可移植胚胎数

指标类型:

主要指标 

Outcome:

number of transferable embryos

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:

颗粒细胞

组织:

Sample Name:

cumulus granulosa cells

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 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):

使用计算机软件产生随机数字,一个专门的护士拆开密封的信封,计算机软件按照2:1的比例,随机分为生长激素伴随用药和对照组

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

Subjects were randomly assigned in a 2 : 1 ratio to receive treatment with either pretreatment with growth hormone supplement or not via a sealed envelope with random numbers generated by computer.

盲法:

未说明

Blinding:

Not stated

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):

重庆市妇幼保健院遗传与生殖研究所, ResMan

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

Chongqing Reproduction and Genetics Institute, Chongqing Health Center for Women and Children; 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:

电子采集管理系统

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

Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-19
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