今天是:2018-01-19 星期五

評估冷凍胚胎移植前子宮內膜搔刮對婦女子宮內膜特征影響之研究
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注册号:

Registration number:

ChiCTR1800014443 

最近更新日期:

Date of Last Refreshed on:

2018-01-14 

注册时间:

Date of Registration:

2018-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

評估冷凍胚胎移植前子宮內膜搔刮對婦女子宮內膜特征影響之研究 

Public title:

A study to compare the endometrial features of women who did and did not benefit from endometrial scratch in the cycle preceding frozen embryo transfer 

研究课题的正式科学名称:

評估冷凍胚胎移植前子宮內膜搔刮對婦女子宮內膜特征影響之研究 

Scientific title:

A study to compare the endometrial features of women who did and did not benefit from endometrial scratch in the cycle preceding frozen embryo transfer 

研究课题代号(代码):

Study subject ID:

2016.673 

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:

CUHK_CCRB00578 

申请注册联系人:

Cheung Wing Ching 

研究负责人:

Prof Li Tin Chiu 

Applicant:

Cheung Wing Ching 

Study leader:

Prof Li Tin Chiu 

申请注册联系人电话:

Applicant telephone:

+852 3505 1764 

研究负责人电话:

Study leader's telephone:

+852 3505 2800 

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:

cosycheung@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

tinchiu.li@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/?ref_no=CUHK_CCRB00578&title_scientific=&title_chinese 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/?ref_no=CUHK_CCRB00578&title_scientific=&title_chinese 

申请注册联系人通讯地址:

1F, 1 Floor, EF block (special block), Department of OG, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China 

研究负责人通讯地址:

1F, 1 Floor, EF block (special block), Department of OG, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China 

Applicant address:

1F, 1 Floor, EF block (special block), Department of OG, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China 

Study leader's address:

1F, 1 Floor, EF block (special block), Department of OG, Prince of Wales Hospital, Shatin, N.T., Hong Kong, 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:

Department of OG 

Applicant's institution:

Department of OG 

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:

2016.673 

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:

Joint CUHK-NTEC Clinical Research Ethics Committee 

Name of the ethic committee:

Joint CUHK-NTEC Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

Prince of Wales Hospital, The Chinese University of Hong Kong 

Primary sponsor:

Prince of Wales Hospital, The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

Nil 

Primary sponsor's address:

Nil 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

N/A 

Source(s) of funding:

N/A 

研究疾病:

infertility 

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:

I期临床试验 

Study phase:

I (Phase I study) 

研究目的:

評估冷凍胚胎移植前子宮內膜搔刮對婦女子宮內膜特征影響 

Objectives of Study:

To compare the endometrial features of women who did and did not benefit from endometrial scratch in the cycle preceding frozen embryo transfer 

药物成份或治疗方案详述:

Several meta-analysis and a recent report from Cochrane database suggested that Mechanical endometrial injury (biopsy/scratch or hysteroscopy) performed sometime during the month before the start of ovarian stimulation could improve the chances that a woman will achieve live birth and clinical pregnancy although a recent RCT suggested endometrial injury in unselected subfertile women undergoing IVF did not appear to be beneficial. Consequently, it is necessary to identify and evaluate which group of women would benefit from endometrial scratch prior to IVF-ET treatment. In particular, there have been several RCTs examining the value of endometrial scratch in the luteal phase in women with unexplained RIF. Because of the difference in the method and timing used for inducing injury, there is considerable heterogeneity in the studies. The overall conclusion of these studies suggests that endometrial scratch is beneficial in women with RIF but should be carried out around the time of embryo implantation, and endometrial scratch could simply be performed by the use of a pipelle endometrial biopsy sampler. Several recent systematic reviews and meta-analyses showed a significant improvement in clinical pregnancy rate after endometrial scratch in women with RIF but suggested further robust randomized trials. 

Description for medicine or protocol of treatment in detail:

Several meta-analysis and a recent report from Cochrane database suggested that Mechanical endometrial injury (biopsy/scratch or hysteroscopy) performed sometime during the month before the start of ovarian stimulation could improve the chances that a woman will achieve live birth and clinical pregnancy although a recent RCT suggested endometrial injury in unselected subfertile women undergoing IVF did not appear to be beneficial. Consequently, it is necessary to identify and evaluate which group of women would benefit from endometrial scratch prior to IVF-ET treatment. In particular, there have been several RCTs examining the value of endometrial scratch in the luteal phase in women with unexplained RIF. Because of the difference in the method and timing used for inducing injury, there is considerable heterogeneity in the studies. The overall conclusion of these studies suggests that endometrial scratch is beneficial in women with RIF but should be carried out around the time of embryo implantation, and endometrial scratch could simply be performed by the use of a pipelle endometrial biopsy sampler. Several recent systematic reviews and meta-analyses showed a significant improvement in clinical pregnancy rate after endometrial scratch in women with RIF but suggested further robust randomized trials. 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

Women undergoing frozen embryo transfer cycles who fulfilled the diagnostic criteria for recurrent implantation failure 

Inclusion criteria

Women undergoing frozen embryo transfer cycles who fulfilled the diagnostic criteria for recurrent implantation failure 

排除标准:

1. Women older than 40 years; 2. Women who have any uterine anomaly or intrauterine pathology such as: Endometrial polyp; 3. Large fibroid with a diameter >4 cm; 4. Visible hydrosalpinx on transvaginal ultrasound scans; 5. BMI >35. 

Exclusion criteria:

1. Women older than 40 years; 2. Women who have any uterine anomaly or intrauterine pathology such as: Endometrial polyp; 3. Large fibroid with a diameter >4 cm; 4. Visible hydrosalpinx on transvaginal ultrasound scans; 5. BMI >35. 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

Case series

样本量:

120

Group:

Case series

Sample size:

干预措施:

Luteinization Hormone (LH) surge + 7 days

干预措施代码:

Intervention:

Luteinization Hormone (LH) surge + 7 days

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

Prince of Wales Hospital 

单位级别:

Prince of Wales Hospital 

Institution
hospital:

Prince of Wales Hospital  

Level of the institution:

Prince of Wales Hospital 

测量指标:

Outcomes:

指标中文名:

examine uterine endometrial markers and association with subsequent IVF outcome

指标类型:

主要指标 

Outcome:

examine uterine endometrial markers and association with subsequent IVF outcome

Type:

Primary indicator 

测量时间点:

LH + 7 days

测量方法:

Endometrial biopsy for immunohistochemistry, immunofluorescence and transcriptome study

Measure time point of outcome:

LH + 7 days

Measure method:

Endometrial biopsy for immunohistochemistry, immunofluorescence and transcriptome study

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 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):

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 after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-12
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