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体外受精周期中经阴道小卵泡穿刺术(TVOD)改善PCOS患者卵巢低反应
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注册号:

Registration number:

ChiCTR1900023612 

最近更新日期:

Date of Last Refreshed on:

2019-06-04 

注册时间:

Date of Registration:

2019-06-04 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

体外受精周期中经阴道小卵泡穿刺术(TVOD)改善PCOS患者卵巢低反应 

Public title:

Transvaginal ovarian drilling improves ovarian response in poor responders with polycystic ovary syndrome undergoing IVF 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

IVF促排卵过程中经阴道小卵泡穿刺对于改善多囊卵巢综合征低反应患者的卵巢反应性的前瞻性队列研究 

Scientific title:

Improvement of ovarian response via transvaginal ovarian drilling in poor ovarian patients with polycystic ovary syndrome undergoing in vitro fertilization-prospective cohort study 

研究课题代号(代码):

Study subject ID:

国家自然科学基金(81300548,81701513, 81771656, and 81873857)上海市教育委员会 - 高峰临床医学资助计划(20181803) 

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:

周明娟 

研究负责人:

徐步芳 

Applicant:

Mingjuan Zhou 

Study leader:

Bufang Xu 

申请注册联系人电话:

Applicant telephone:

+86 15800385575 

研究负责人电话:

Study leader's telephone:

+86 02164370045-601700 

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:

MJzhou93@163.com 

研究负责人电子邮件:

Study leader's E-mail:

bufangxu@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:

上海市瑞金二路197号上海交通大学医学院附属瑞金医院 

研究负责人通讯地址:

上海市瑞金二路197号上海交通大学医学院附属瑞金医院 

Applicant address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Huangpu District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200025 

研究负责人邮政编码:

Study leader's postcode:

200025 

申请人所在单位:

上海交通大学医学院附属瑞金医院生殖中心 

Applicant's institution:

Reproductive Medical Center of Ruijin Hospital School of Medicine, Shanghai Jiao Tong 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:

(2015)临伦审第(92)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:

上海交通大学医学院附属瑞金医院伦理委员会 

Name of the ethic committee:

Ruijin hospital ethics committee Shanghaijiaotong University School of Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-11-25 

伦理委员会联系人:

王译锋 

Contact Name of the ethic committee:

Yifeng Wang 

伦理委员会联系地址:

上海市瑞金二路197号上海交通大学医学院附属瑞金医院 

Contact Address of the ethic committee:

Ruijin Hospital School of Medicine, Shanghai Jiao Tong University, 197 Second Ruijin Road, Huangpu District, Shanghai, 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:

上海交通大学医学院附属瑞金医院生殖中心 

Primary sponsor:

Reproductive Medical Center of Ruijin Hospital School of Medicine, Shanghai Jiao Tong University 

研究实施负责(组长)单位地址:

上海交通大学医学院附属瑞金医院生殖中心 

Primary sponsor's address:

197 Second Ruijin Road, Huangpu District, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学医学院附属瑞金医院

具体地址:

上海市瑞金二路197号上海交通大学医学院附属瑞金医院

Institution
hospital:

Ruijin Hospital School of Medicine, Shanghai Jiao Tong University

Address:

197 Second Ruijin Road, Huangpu District, Shanghai, China

经费或物资来源:

国家自然科学基金(81300548,81701513, 81771656, and 81873857)上海市教育委员会 - 高峰临床医学资助计划(20181803) 

Source(s) of funding:

Natural Science Foundation of China (81300548, 81701513, 81771656, and 81873857); Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant Support (20181803) 

研究疾病:

多囊卵巢综合征 

Target disease:

polycystic ovary syndrome 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

评估经阴道小卵泡穿刺(TVOD)对改善IVF治疗周期中PCOS患者卵巢反应的效果,并研究其内的潜在机制。 

Objectives of Study:

To investigate the mechanism underlying ovarian resistance in the poor ovarian PCOS patients, and evaluate the utility of transvaginal ovarian drilling (TVOD) in improving the ovarian response. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

根据鹿特丹标准诊断患有PCOS的患者:(i)少经或闭经(周期> 35天),(ii)雄激素过多(定义为Ferriman-Gallwey评分为≥8,睾酮> 2.5 nmol / l,和/或雄烯二酮> 9.0 nmol / l),(iii)多囊卵巢形态(至少1个卵巢≥12个卵泡[2-9 mm])。将这些患者按促排卵时卵巢的反应分为3组:1)低反应者(促性腺激素连续刺激2周,激素用量达450 IU [至少7天],患者无或<3个优势卵泡);2)正常反应者(用药刺激2周内有5-15个优势卵泡发育,HCG扳机日E2水平<4200 pg / ml);3)高反应者(连续刺激后2周内多余15个卵泡发育,HCG扳机日E2水平> 4200 pg / ml)。 

Inclusion criteria

We enrolled women who were diagnosed with PCOS based on the presence of all the Rotterdam criteria: 1. oligo- or amenorrhea (cycle>35 days); 2. bio-chemical/clinical hyperandrogenism (defined as a Ferriman-Gallwey score of ≥8, testosterone >2.5 nmol/l, and/or androstenedione >9.0 nmol/l); and 3. polycystic ovarian morphology (≥12 follicles [2–9 mm] in at least 1 ovary). Patients with hyperinsulinemia were administered metformin for 2–3 months to decrease the insulin levels to normal levels. These patients were categorized into 3 groups: 1) poor responders (no or <3 dominant follicles developed after 2 weeks under gradual stimulation with gonadotrophin up to 450 IU [at least 7 days]); 2) normal responders (5–15 dominant follicles developed within 2 weeks of stimulation, with the E2 level <4200 pg/ml on the trigger day;); 3) high responders (>15 dominant follicles developed within 2 weeks of stimulation, with the E2 level > 4200 pg/ml on the trigger day).  

排除标准:

排除标准包括:曾行卵巢手术;患者患有内分泌疾病(糖尿病,雌激素依赖性肿瘤,甲状腺疾病,库欣综合征或先天性肾上腺增生等) 

Exclusion criteria:

Previous ovarian surgery and co-existing endocrine diseases (diabetes mellitus, estrogen-dependent tumors, thyroid disease, Cushings syndrome, or congenital adrenal hyperplasia). 

研究实施时间:

Study execute time:

From2015-12-01To 2019-07-02 

干预措施:

Interventions:

组别:

1

样本量:

7

Group:

1

Sample size:

干预措施:

经阴道卵泡穿刺术

干预措施代码:

Intervention:

Transvaginal ovarian drilling

Intervention code:

组别:

2

样本量:

28

Group:

2

Sample size:

干预措施:

取卵当天穿刺小卵泡

干预措施代码:

Intervention:

small follicle drilling on the ovum pick-up

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属瑞金医院 

单位级别:

三级甲等医院 

Institution
hospital:

Ruijin Hospital School of Medicine, Shanghai Jiao Tong University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

卵巢反应

指标类型:

主要指标 

Outcome:

ovarian respone

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠结局

指标类型:

主要指标 

Outcome:

Pregnancy outcome

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

激素水平

指标类型:

主要指标 

Outcome:

hormone levels

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者基本信息

指标类型:

次要指标 

Outcome:

Demographic clinical characteristics

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:

卵泡穿刺液

组织:

Sample Name:

follicluar fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血清

组织:

Sample Name:

serum

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 years
最大 Max age 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:

N/A

Blinding:

N/A

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):

项目组根据研究进程择期选择具体方式公开原始数据; ResMan

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

According to the progress of the research,raw research data should be made freely available to all researchers in specfic ways; 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:

研究者采用Excel表格录入数据,并采用SPSS 22.0进行统计分析

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

The researchers use Excel to enter data, and use SPSS 22.0 for statistical analysis.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-04
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