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 |
注册题目简写: |
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English Acronym: |
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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: |
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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: |
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申请人所在单位: |
Department of OG |
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Applicant's institution: |
Department of OG |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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批准本研究的伦理委员会名称: |
Joint CUHK-NTEC Clinical Research Ethics Committee |
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Name of the ethic committee: |
Joint CUHK-NTEC Clinical Research Ethics Committee |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
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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: |
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Target disease code: |
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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: |
从From至To |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
女性 |
Gender: |
Female |
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随机方法(请说明由何人用什么方法产生随机序列): |
N/A |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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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-based 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 |