今天是:2022-01-25 星期二

基于子宫内膜容受性检测和非侵入性胚胎植入前潜能评估的多囊卵巢综合征患者个体化移植策略研究
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注册号:

Registration number:

ChiCTR2100053824 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于子宫内膜容受性检测和非侵入性胚胎植入前潜能评估的多囊卵巢综合征患者个体化移植策略研究 

Public title:

Personalized transplantation strategies for patients with polycystic ovary syndrome based on endometrial receptivity testing and non-invasive embryo preimplantation potential assessment 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于子宫内膜容受性检测和非侵入性胚胎植入前潜能评估的多囊卵巢综合征患者个体化移植策略研究 

Scientific title:

Personalized transplantation strategies for patients with polycystic ovary syndrome based on endometrial receptivity testing and non-invasive embryo preimplantation potential assessment 

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:

曾玖芝 

研究负责人:

曾玖芝 

Applicant:

Zeng Jiuzhi 

Study leader:

Zeng Jiuzhi 

申请注册联系人电话:

Applicant telephone:

18908098215 

研究负责人电话:

Study leader's telephone:

18908098215 

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:

zengjiuzhi9@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zengjiuzhi9@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:

四川省成都市武侯区沙堰村西二街209号 

研究负责人通讯地址:

四川省成都市武侯区沙堰村西二街209号 

Applicant address:

No.290, West 2nd Street, Shayan, Wuhou District, Chengdu City, Sichuan Province 

Study leader's address:

No.290, West 2nd Street, Shayan, Wuhou District, Chengdu City, Sichuan Province 

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:

四川省妇幼保健院 

Applicant's institution:

Sichuan Provincial Maternity and Child Health Care Hospital 

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:

2021-002 

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:

四川省妇幼保健院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sichuan Provincial Maternity and Child Health Care Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-04-20 

伦理委员会联系人:

王献民 

Contact Name of the ethic committee:

Wang Xianmin 

伦理委员会联系地址:

四川省成都市武侯区沙堰村西二街209号 

Contact Address of the ethic committee:

No.290, West 2nd Street, Shayan, Wuhou District, Chengdu City, Sichuan Province 

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:

四川省妇幼保健院 

Primary sponsor:

Sichuan Provincial Maternity and Child Health Care Hospital 

研究实施负责(组长)单位地址:

四川省成都市武侯区沙堰村西二街209号 

Primary sponsor's address:

No.290, West 2nd Street, Shayan, Wuhou District, Chengdu City, Sichuan Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川省妇幼保健院

具体地址:

四川省成都市武侯区沙堰村西二街209号

Institution
hospital:

Sichuan Provincial Maternity and Child Health Care Hospital

Address:

No.290, West 2nd Street, Shayan, Wuhou District, Chengdu City, Sichuan Province

经费或物资来源:

四川省妇幼保健协会科研项目 

Source(s) of funding:

Research Project of Sichuan Maternity and Child Health Association 

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:

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.比较联合ERA和EMBRACE指导的个体化胚胎移植与单用EMBRACE和传统胚胎移植方案对PCOS患者临床结局的影响; 2.研究PCOS患者的WOI移位特点,经ERA检测实施个体化胚胎移植后改善妊娠结局的有效性; 3.比较单用EMBRACE指导的个体化胚胎移植与常规移植比较结局差异,评价EMBRACE这种无创胚胎检测方法用于改善妊娠结局的效果。 

Objectives of Study:

1. To compare the effects of individualized embryo transfer guided by ERA and EMBRACE with EMBRACE alone and traditional embryo transfer on the clinical outcome of PCOS patients; 2. To study the characteristics of WOI displacement in PCOS patients, and the effectiveness of improving pregnancy outcome by individualized embryo transfer after ERA test; 3. To compare the outcome differences of the individualized embryo transfer guided by EMBRACE alone with the conventional transplantation, and evaluate the effect of EMBRACE, a non-invasive embryo detection method, for improving pregnancy outcomes. 

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女方年龄20-37岁; ②BMI指数18-28kg/m2; ③符合PCOS诊断标准; ④具有IVF/ICSI指征,囊胚培养,全胚冷冻; 

Inclusion criteria

① Female aged 20-37 years old; ②BMI index 18-28kg/m2; ③Conform to PCOS diagnostic criteria; ④With IVF/ICSI indication, blastocyst culture, whole embryo freezing; 

排除标准:

①可能影响着床的子宫病变(包括宫腔粘连史、子宫内膜息肉、子宫内膜炎、子宫内膜结核、子宫内膜增生、薄型子宫内膜、粘膜下肌瘤、子宫腺肌病),子宫畸形; ②有输卵管积液宫腔返流依据的未经处理的严重输卵管积水; ③未经治疗的严重的内外科疾病; ④计划PGT的患者; ⑤其他研究者认为不适合参加本研究的任何情况,例如:精神因素等; 

Exclusion criteria:

① Uterine diseases that may affect implantation (including the history of intrauterine adhesions, endometrial polyps, endometritis, endometrial tuberculosis, endometrial hyperplasia, thin endometrium, submucosal fibroids, adenomyosis), Uterine malformation; ②Untreated severe hydrosalpinx that is diagnosed with tubal effusion and uterine reflux; ③Severe medical and surgical diseases that have not been treated; ④Patients planning PGT; ⑤ Any situation that other researchers think is not suitable for participating in this research, such as mental factors, etc.; 

研究实施时间:

Study execute time:

From2021-07-01To 2023-07-01 

征募观察对象时间:

Recruiting time:

From2022-01-01To 2023-03-31 

干预措施:

Interventions:

组别:

研究组1

样本量:

50

Group:

Study Group 1

Sample size:

干预措施:

经ERA+EMBRACE检测的胚胎移植

干预措施代码:

Intervention:

embryo transfer guided by ERA and EMBRACE

Intervention code:

组别:

研究组2

样本量:

50

Group:

Study Group 2

Sample size:

干预措施:

经EMBRACE检测的胚胎移植

干预措施代码:

Intervention:

embryo transfer guided by EMBRACE alone

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

传统胚胎移植

干预措施代码:

Intervention:

traditional embryo transfer

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川省妇幼保健院 

单位级别:

三级甲等医院 

Institution
hospital:

Sichuan Provincial Maternity and Child Health Care Hospital  

Level of the institution:

grade A tertiary 

测量指标:

Outcomes:

指标中文名:

宫内临床妊娠率

指标类型:

主要指标 

Outcome:

Intrauterine 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:

胚胎种植率

指标类型:

次要指标 

Outcome:

Embryo implantation rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

流产率

指标类型:

次要指标 

Outcome:

Miscarriage rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

持续临床妊娠率

指标类型:

次要指标 

Outcome:

Ongoing clinical pregnancy rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活产率

指标类型:

次要指标 

Outcome:

Live birth rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

新生儿出生体重

指标类型:

次要指标 

Outcome:

Birth weight of newborn

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

母胎/母儿并发症

指标类型:

次要指标 

Outcome:

Maternal/fetal complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生化妊娠率

指标类型:

次要指标 

Outcome:

Biochemical Pregnancy Rate

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:

子宫内膜

组织:

子宫腔

Sample Name:

Endometrium

Tissue:

Uterine cavity

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 37 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):

本项目采用简单随机化分组,将病历从1-150编号,从随机数字表随机选取一个起始数字,沿同一方向获取随机数字,随机数字除以组数得余数,如整除则余数取组数,按照余数分组。

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

This project uses simple randomization grouping, numbering the medical records from 1-150, randomly selecting a starting number from the random number table, and obtaining random numbers in the same direction. The random number is divided by the number of groups to obtain the remainder. If the number is com

盲法:

该项目不设盲,是一项开放标签的临床试验。

Blinding:

The project is not blinded and is an open-label clinical trial.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

不共享数据

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

Not shared data

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:

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-11-30
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