Today is 2019-12-07

Effect of growth hormone on the outcome of IVF-ET in PCOS patients
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注册号:

Registration number:

ChiCTR1900027647 

最近更新日期:

Date of Last Refreshed on:

2019-11-22 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

生长激素对PCOS患者体外受精-胚胎移植治疗结局的影响 

Public title:

Effect of growth hormone on the outcome of IVF-ET in PCOS patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

生长激素对PCOS患者体外受精-胚胎移植治疗结局的影响 

Scientific title:

Effect of growth hormone on the outcome of IVF-ET in PCOS patients 

研究课题代号(代码):

Study subject ID:

2018-CXB-29 

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:

邬晓琳 

研究负责人:

李萍 

Applicant:

Wu Xiaolin 

Study leader:

Li Ping 

申请注册联系人电话:

Applicant telephone:

+86 17759276103 

研究负责人电话:

Study leader's telephone:

+86 13950078214 

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:

413884600@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

daring@stu.xmu.edu.cn 

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:

福建省厦门市思明区镇海路10号 

研究负责人通讯地址:

福建省厦门市思明区镇海路10号 

Applicant address:

10 Zhenhai Road, Siming District, Xiamen, Fujian, China 

Study leader's address:

10 Zhenhai Road, Siming District, Xiamen, Fujian, 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:

厦门大学附属妇女儿童医院 

Applicant's institution:

Women and Children's Hospital of Xiamen 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:

KY-2019-028 

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:

厦门市妇幼保健院人体研究伦理委员会 

Name of the ethic committee:

Xiamen maternal and child health care hospital human body research ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-30 

伦理委员会联系人:

周裕林 

Contact Name of the ethic committee:

Zhou Yulin 

伦理委员会联系地址:

福建省厦门市思明区镇海路10号 

Contact Address of the ethic committee:

10 Zhenhai Road, Siming District, Xiamen, Fujian, China 

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:

厦门大学附属妇女儿童医院 

Primary sponsor:

Women and Children's Hospital of Xiamen University 

研究实施负责(组长)单位地址:

福建省厦门市思明区镇海路10号 

Primary sponsor's address:

10 Zhenhai Road, Siming District, Xiamen, Fujian, 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):

福建省

市(区县):

厦门市

Country:

China

Province:

Fujian Province

City:

Xiamen

单位(医院):

厦门大学附属妇女儿童医院

具体地址:

福建省厦门市思明区镇海路10号

Institution
hospital:

Women and Children's Hospital of Xiamen University

Address:

10 Zhenhai Road, Siming District

经费或物资来源:

福建省医学创新课题(2018-CXB-29) 

Source(s) of funding:

Fujian medical innovation project (2018-CXB-29) 

研究疾病:

多囊卵巢综合征 

Target disease:

polycystic ovarian syndrome 

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:

1.对PCOS患者在IVF-ET控制性超促排卵治疗中加用人生长激素,通过观察生长激素对妊娠结局的影响,比较在非IR组与IR组存在的疗效差异,总结生长激素在不同类型PCOS患者行IVF-ET中的应用价值。 2.评估PCOS患者对于人生长激素辅助治疗可能出现预期的不良反应,以期对临床应用提供一些建议。 

Objectives of Study:

1. Human growth hormone was used in the treatment of ivf-et controlled hyperovulation in PCOS patients. By observing the effect of growth hormone on pregnancy outcome, the difference in efficacy between non-ir group and IR group was compared, and the application value of growth hormone in ivf-et in different types of PCOS patients was summarized. 2. Evaluate the potential adverse reactions of PCOS patients to human growth hormone adjuvant therapy, so as to provide some Suggestions for clinical application. 

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.体质指数( BMI):18.5≤BMI<28kg/m2; 2.年龄≤35岁; 3.助孕指征为PCOS,以及PCOS并发输卵管因素; 4.均为第一个超促排卵周期 

Inclusion criteria

1. Body mass index (BMI) 18.5 to 28kg/m2; 2. Aged <=35 years old; 3. The indication of pregnancy assistance is PCOS, and the factors of PCOS complicated with fallopian tubes; 4. All were the first COH cycle 

排除标准:

1.男方重度少弱畸精子症; 2.既往有卵巢手术史、先天性子宫畸形、子宫内膜异位症、子宫腺肌病、宫腔粘连等 3.伴有其他内分泌疾病如高泌乳血症、甲状腺功能异常、糖尿病等。 

Exclusion criteria:

1. Severe oligospermia for male; 2. Previous ovarian surgery, congenital uterine malformation, endometriosis, adenomyosis, uterine cavity adhesion, etc 3. Accompanied by other endocrine diseases, such as hyperprolacemia, abnormal thyroid function, diabetes, etc. 

研究实施时间:

Study execute time:

From2019-12-01To 2020-12-01 

干预措施:

Interventions:

组别:

1组

样本量:

60

Group:

Group 1

Sample size:

干预措施:

生长激素预处理

干预措施代码:

Intervention:

GH pretreatment

Intervention code:

组别:

2组

样本量:

60

Group:

Group 2

Sample size:

干预措施:

不做生长激素预处理

干预措施代码:

Intervention:

No GH pretreatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建省 

市(区县):

厦门市 

Country:

China 

Province:

Fujian Province 

City:

Xiamen 

单位(医院):

厦门大学附属妇女儿童医院 

单位级别:

三甲 

Institution
hospital:

Women and children's hospital of xiamen university  

Level of the institution:

Tertiary A Hospital  

测量指标:

Outcomes:

指标中文名:

获卵数

指标类型:

主要指标 

Outcome:

Number of eggs harvested

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:

组织:

Sample Name:

blod

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 22 years
最大 Max age 35 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):

随机数法

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

Microsoft excel generates random numbers

盲法:

未说明

Blinding:

Not stated

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:

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):

2021年5月

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

2021.5

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:

EDC

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-11-22
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