补肾调经系列方对肾虚不孕症患者辅助生殖妊娠结局影响

注册号:

Registration number:

ITMCTR2200005490

最近更新日期:

Date of Last Refreshed on:

2021-12-31

注册时间:

Date of Registration:

2021-12-31

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

补肾调经系列方对肾虚不孕症患者辅助生殖妊娠结局影响

Public title:

Influence of Bushen Tiaojing Series Prescriptions on Assisted Reproductive Pregnancy Outcomes in Patients with Kidney Deficiency and Infertility

注册题目简写:

English Acronym:

研究课题的正式科学名称:

补肾调经系列方对肾虚不孕症患者辅助生殖妊娠结局影响

Scientific title:

Influence of Bushen Tiaojing Series Prescriptions on Assisted Reproductive Pregnancy Outcomes in Patients with Kidney Deficiency and Infertility

研究课题的正式科学名称简写:

Scientific title acronym:

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:

ChiCTR2100055048 ; ChiMCTR2200005490

申请注册联系人:

闫梦璇

研究负责人:

刘雪平

Applicant:

yanmengxuan

Study leader:

liuxueping

申请注册联系人电话:

Applicant telephone:

13932123972

研究负责人电话:

Study leader's telephone:

15100083589

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:

yanmaxmax@163.com

研究负责人电子邮件:

Study leader's E-mail:

965782894@qq.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

河北中医学院

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:

河北省石家庄市桥西区新石南路326号

研究负责人通讯地址:

河北省石家庄市桥西区新石南路326号

Applicant address:

No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei Province

Study leader's address:

No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei 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:

河北中医学院

Applicant's institution:

Hebei University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

YXLL2019008

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:

河北中医学院伦理委员会

Name of the ethic committee:

Ethics Committee of Hebei College of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2019/3/4 0:00:00

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:

河北中医学院

Primary sponsor:

Hebei University of Chinese Medicine

研究实施负责(组长)单位地址:

河北省石家庄市桥西区新石南路326号

Primary sponsor's address:

No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei 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):

河北

市(区县):

Country:

China

Province:

Hebei

City:

单位(医院):

石家庄市妇产医院

具体地址:

河北省石家庄市长安区中山东路206号

Institution
hospital:

Shijiazhuang Obstetrics and Gynecology Hospital

Address:

206 Zhongshan Dong Road, Chang'an District, Shijiazhuang City, Hebei Province

国家:

中国

省(直辖市):

河北

市(区县):

Country:

China

Province:

Hebei

City:

单位(医院):

河北中医学院

具体地址:

河北省石家庄市桥西区新石南路326号

Institution
hospital:

Hebei University of Chinese Medicine

Address:

No. 326, Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei Province

经费或物资来源:

国家自然科学基金

Source(s) of funding:

The National Natural Science Foundation of China

研究疾病:

不孕症

研究疾病代码:

Target disease:

Infertility

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

补肾调经系列方对肾虚不孕症患者辅助生殖妊娠结局及卵丘扩展相关因子的影响

Objectives of Study:

Influence of Bushen Tiaojing Series Recipes on Assisted Reproductive Pregnancy Outcomes and Cumulus Expansion Related Factors in Patients with Kidney Deficiency and Infertility

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)符合不孕症诊断标准及中医辨证标准;(2)年龄≤35岁;(3)生殖道无器质性病变;(4)双侧输卵管不通畅;(5)男方精液检查正常;(6)接受IVF-ET或卵胞浆内单精子注射-胚胎移植助孕;(7)自愿接受试验,治疗及受孕后接受随访。

Inclusion criteria

(1) Meet the diagnostic criteria of infertility and the criteria of TCM syndrome differentiation; (2) Age ≤ 35 years; (3) No organic disease in the reproductive tract; (4) Bilateral fallopian tubes are not unblocked; (5) The man's semen examination is normal; (6) Receiving IVF-ET or intracytoplasmic sperm injection-embryo transfer to assist pregnancy; (7) Voluntary trial, treatment and follow-up after conception.

排除标准:

(1)不符合不孕症诊断标准及中医辨证标准;(2)年龄>35岁;(3)生殖器官畸形、先天性性腺发育不全及子宫性闭经等器质病变;(4)3个月内应用激素类药物治疗者;(5)子宫内膜异位症、子宫内膜息肉、宫腔粘连等;(6)合并心脑血管、肝、肾和造血系统等严重原发性疾病;(7)双侧卵巢或单侧卵巢切除引起的卵巢功能早衰。

Exclusion criteria:

(1) Does not meet the diagnostic criteria of infertility and TCM syndrome differentiation criteria; (2) Age> 35 years old; (3) Organic diseases such as genital malformations, congenital gonadal hypoplasia, and uterine amenorrhea; (4) 3 months Those who are treated with hormone drugs; (5) Endometriosis, endometrial polyps, intrauterine adhesions, etc.; (6) Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; ( 7) Premature ovarian failure caused by removal of both ovaries or unilateral ovaries.

研究实施时间:

Study execute time:

From 2020-10-01

To      2021-10-01

征募观察对象时间:

Recruiting time:

From 2020-10-01

To      2021-10-01

干预措施:

Interventions:

组别:

治疗组

样本量:

27

Group:

Treatment group

Sample size:

干预措施:

中药+西药

干预措施代码:

Intervention:

Chinese Medicine + Western Medicine

Intervention code:

组别:

对照组

样本量:

28

Group:

Control group

Sample size:

干预措施:

西药

干预措施代码:

Intervention:

Western Medicine

Intervention code:

样本总量 Total sample size : 55

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河北

市(区县):

Country:

China

Province:

Hebei

City:

单位(医院):

石家庄市妇产医院

单位级别:

三级甲等

Institution/hospital:

Shijiazhuang Obstetrics and Gynecology Hospital

Level of the institution:

Grade 3A

测量指标:

Outcomes:

指标中文名:

促性腺激素总量

指标类型:

主要指标

Outcome:

Total gonadotropins

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

雌二醇

指标类型:

主要指标

Outcome:

estradiol

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

获卵数

指标类型:

主要指标

Outcome:

number of oocytes obtained

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分

指标类型:

主要指标

Outcome:

TCM Evidence Score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胚胎数

指标类型:

主要指标

Outcome:

embryos obtained

Type:

Primary 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:

卵泡液

组织:

Sample Name:

Follicular 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:

征募研究对象情况:

结束

Completed

年龄范围:

最小 22
Min age years
最大 35
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

采用1:1完全随机原则,根据总样本量编号1-60,应用SPSS软件生成随机数字,按照随机数字由大到小排序,根据各组样本量随机分配到不同处理组。

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

The 1:1 principle of complete randomness was used, with numbers 1-60 based on the total sample size, and SPSS software was applied to generate random numbers, which were sorted from largest to smallest according to the random number, and randomly assigned to different treatment groups according to the sampl

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

ResMan

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

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:

ResMan

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

ResMan

数据管理委员会:

Data Managemen Committee:

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统