针药预培其损干预高龄肾虚型DOR女性IVF/ICSI-ET结局的前瞻性队列研究

注册号:

Registration number:

AMCTR-OOC-19000243 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 18:47:06 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针药预培其损干预高龄肾虚型DOR女性IVF/ICSI-ET结局的前瞻性队列研究 

Public title:

A prospective cohort study for IVF / ICSI-ET outcomes of intervention in elderly renal deficiency DOR women by joint acupuncture and traditional Chinese medicine pretreatment 

研究课题的正式科学名称:

针药预培其损干预高龄肾虚型DOR女性IVF/ICSI-ET结局的前瞻性队列研究 

Scientific title:

A prospective cohort study for IVF / ICSI-ET outcomes of intervention in elderly renal deficiency DOR women by joint acupuncture and traditional Chinese medicine pretreatment 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1900020533 

申请注册联系人:

洪岩 

研究负责人:

洪岩 

Applicant:

Hong Yan 

Study leader:

Hong Yan 

申请注册联系人电话:

Applicant telephone:

+86 13917858864 

研究负责人电话:

Study leader's telephone:

+86 13917858864 

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:

chuanliubuxi31@126.com 

研究负责人电子邮件:

Study leader's E-mail:

chuanliubuxi31@126.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:

上海市普陀区新村路389号 

研究负责人通讯地址:

上海市普陀区新村路389号 

Applicant address:

389 Xincun Road, Putuo District, Shanghai, China 

Study leader's address:

389 Xincun Road, Putuo District, Shanghai, 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:

同济大学附属同济医院 

Applicant's institution:

Tongji Hospital Affiliated to Tongji 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:

伦理申请中 

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:

同济大学附属同济医院医学伦理委员会 

Name of the ethic committee:

Ethics committee of Tongji Hospital Affiliated to Tongji University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

同济大学附属同济医院 

Primary sponsor:

Tongji Hospital Affiliated to Tongji University 

研究实施负责(组长)单位地址:

上海市普陀区新村路389号 

Primary sponsor's address:

389 Xincun Road, Putuo 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(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

同济大学附属同济医院

具体地址:

上海市普陀区新村路389号

Institution
hospital:

Tongji Hospital Affiliated to Tongji University

Address:

389 Xincun Road, Putuo District, Shanghai, China

经费或物资来源:

无 

Source(s) of funding:

No 

研究疾病:

不孕症 

Target disease:

Infertility 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

本研究以高龄肾虚型DOR女性为研究对象,观察针药结合预处理改善IVF/ICSI-ET助孕周期中相关指标的效果,为改善卵巢储备功能、降低高龄女性IVF-ET发生POR风险、提高临床妊娠率、探索ART的中西医结合方法提供临床研究依据。 

Objectives of Study:

This study focuses on the elderly renal deficiency DOR women, to observe the effect of pre-treatment of acupuncture combined with traditional Chinese medicine on the improvement of related indicators in the pregnancy cycle of IVF/ICSI-ET. It will provide clinical research basis for improving ovarian storage function, reducing the risk of POR occurrence of IVF-ET in elderly women, improving the clinical pregnancy rate, and exploring ART combined Chinese and Western medicine methods. 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1 年龄在35-42岁之间; 2 符合行IVF/ICSI-ET的适应症; 3 符合DOR的诊断标准; 4 符合中医肾虚型证候诊断; 5 不孕原因主要为输卵管因素,并排除下丘脑垂体疾病及其他内分泌疾病(甲状腺功能减退或亢进、糖尿病等)、多囊卵巢综合征(polycystic ovarian syndrome,PCOS)、严重的盆腔子宫内膜异位症、子宫腺肌症等; 6患者同意参加本临床研究并签署知情同意书。 

Inclusion criteria

1. Aged between 35 and 42 years old; 2. conforms to the indications for IVF/ICSI-ET; 3. conforms to the diagnostic criteria of DOR; 4. conforms to the diagnostic criteria of renal deficiency syndrome in Chinese medicine; 5. The main causes of infertility are fallopian tube factors, and exclude hypothalamus and other endocrine diseases(hypothyroidism or hyperthyroidism, diabetes, etc.), polycystic ovary syndrome (PCOS), severe pelvic endometriosis, adenomyosis, etc.; 6. Patients agree to participate in this clinical study and sign an informed consent form. 

排除标准:

1. 3个月内有甾体类激素治疗史及宫腔操作史; 2. 已明确生殖器官有明显而严重的其他器质性病变者; 3. 伴卵巢早衰、既往卵巢手术史及仅存单侧卵巢者; 4. PCOS、子宫腺肌症、子宫畸形、双方染色体异常、卵巢肿瘤以及其他内分泌疾病(糖尿病、甲状腺功能障碍等); 5. 患有《母婴保健法》规定的不宜生育的、目前无法进行胚胎植入前遗传学诊断的遗传性疾病; 6. 夫妇双方合并有心血管、肝、肾和造血系统等严重原发性疾病及精神病患者; 7. 夫妇双方中任何一方具有吸毒等严重不良嗜好及接触致畸量的射线、毒物、药品并处于作用期; 8. 过敏体质及对多种药物过敏者; 9. 不能坚持治疗者。 

Exclusion criteria:

1. Within 3 months, there was a history of steroid hormone treatment and a history of uterine operation; 2. It has been clear that there are obvious and serious other organic lesions in the reproductive organs; 3. With ovarian premature failure, previous ovarian surgery history and only single ovarian; 4. PCOS, adenomyosis, uterine malformations, chromosomal abnormalities, ovarian tumors, and other endocrine diseases(diabetes, thyroid dysfunction, etc.); 5. Hereditary diseases that are not suitable for production, and are currently not capable of being diagnosed by preimplantation genetics under the Maternal and Child Health Act; 6. The couple merged with Severe primary diseases of the cardiovascular, hepatic, renal or hematopoietic systems , or with mental illness; 7. Either of the couple has serious addictions such as drug use and exposure to teratogenic rays, poisons, and drugs and is in the action period; 8. Allergic constitution and allergy to many drugs; 9. Can not insist on treatment. 

研究实施时间:

Study execute time:

From2019-04-01To 2022-03-31 

干预措施:

Interventions:

组别:

暴露组

样本量:

80

Group:

Exposure group

Sample size:

干预措施:

针药结合

干预措施代码:

Intervention:

IVF/ICSI-ET + Acupuncture combined with traditional Chinese medicine

Intervention code:

组别:

对照组

样本量:

80

Group:

Control group

Sample size:

干预措施:

IVF/ICSI-ET

干预措施代码:

Intervention:

IVF/ICSI-ET

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):

同济大学附属同济医院 

单位级别:

三级甲等 

Institution
hospital:

Tongji University Affiliated Tongji Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

优质胚胎率

指标类型:

主要指标 

Outcome:

Quality Embryonic Rate

Type:

Primary indicator 

指标中文名:

临床妊娠率

指标类型:

次要指标 

Outcome:

Clinical pregnancy rate

Type:

Secondary indicator 

指标中文名:

获卵数

指标类型:

次要指标 

Outcome:

Number of eggs obtained

Type:

Secondary indicator 

指标中文名:

证候积分

指标类型:

次要指标 

Outcome:

Chinese medicine syndrome integral

Type:

Secondary indicator 

指标中文名:

2PN数

指标类型:

次要指标 

Outcome:

2PN number,

Type:

Secondary indicator 

指标中文名:

卵裂数

指标类型:

次要指标 

Outcome:

egg split number

Type:

Secondary indicator 

指标中文名:

基础内分泌变化

指标类型:

次要指标 

Outcome:

Fundamental endocrine changes

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

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:

卵泡液

组织:

Sample Name:

Follicle fluid

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:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 42 years

随机方法(请说明由何人用什么方法产生随机序列):

非随机

性别:

女性

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

Non-random

Gender:

Female

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

2025年9月30日联系have_time_off@126.com取得

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

Fromhave_time_off@126.com on September 30, 2022

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

CRF表

The repository and management of the data(Please specify what repository will be used for management of the metadata):

CRF

创建人:

Creater Name:

 2019-01-11
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