补肾促卵方治疗高催乳素血症导致排卵障碍性不孕的有效性和安全性临床研究

注册号:

Registration number:

ITMCTR2024000017

最近更新日期:

Date of Last Refreshed on:

2024-02-05

注册时间:

Date of Registration:

2024-02-05

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

补肾促卵方治疗高催乳素血症导致排卵障碍性不孕的有效性和安全性临床研究

Public title:

Clinical study on the efficacy and safety of Bushen Culuan fang in treating anovulatory infertility caused by hyperprolactinemia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

补肾促卵方治疗高催乳素血症导致排卵障碍性不孕的有效性和安全性临床研究

Scientific title:

Gynecology of traditional Chinese medicine

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:

申请注册联系人:

马丽爽

研究负责人:

马堃

Applicant:

MaLishuang

Study leader:

MaKun

申请注册联系人电话:

Applicant telephone:

13718785915

研究负责人电话:

Study leader's telephone:

13910218105

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:

letianzi81@163.com

研究负责人电子邮件:

Study leader's E-mail:

makun12348@sina.com

申请单位网址(自愿提供):

Study leader's 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:

北京市石景山区鲁谷路33号

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

No. 33 Lugu Road, Shijingshan District, Beijing

Study leader's address:

No. 1 Xiyuan Playground, Haidian District, Beijing

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:

中国中医科学院眼科医院

Applicant's institution:

Eye Hospital ,China Academy of Traditional 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:

2023XLA125-2

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

EC of XiYuan Hospital of China Academy of Chinaese Medical sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2023/12/6 0:00:00

伦理委员会联系人:

徐浩

Contact Name of the ethic committee:

XuHao

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

No. 1 Xiyuan Playground, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

01062835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xiyuanlunli@163.com

研究实施负责(组长)单位:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号

Primary sponsor's address:

No. 1 Xiyuan Playground, Haidian District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

具体地址:

北京市海淀区西苑操场1号

Institution
hospital:

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

Address:

No. 1 Xiyuan Playground, Haidian District, Beijing

经费或物资来源:

中国中医科学院西苑医院

Source(s) of funding:

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

研究疾病:

高催乳素血症

研究疾病代码:

Target disease:

Hyperprolactinemia

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:

观察补肾促卵方治疗高催乳素血症导致排卵障碍性不孕的有效性和安全性。

Objectives of Study:

To observe the efficacy and safety of Bushen promoting eggs prescription in treating ovulation disorder infertility caused by hyperprolactinemia.

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)年龄20-40岁之间; (2)符合不孕症诊断标准; (3)符合高催乳素血症诊断标准; (4)符合中医肾虚血瘀证诊断标准; (5)自愿签署知情同意书者。

Inclusion criteria

(1) Between 20 and 40 years old; (2) Meet the diagnostic criteria for infertility; (3) Meet the diagnostic criteria of hyperprolactinemia; (4) Meet the diagnostic criteria of TCM kidney deficiency and blood stasis syndrome; (5) Voluntarily sign the informed consent.

排除标准:

(1)先天性生理缺陷或畸形所致排卵障碍或不孕者: (2)遗传因素所致不孕者; (3)经检查证实由于输卵管因素,或免疫性因素,或子宫肌瘤,或子宫肌腺病,或子宫内膜异位症,或子宫发育不良所致不孕者; (4)配偶生殖功能异常者; (5)合并心血管、肝、肾或造血系统严重异常; (6)精神神经疾病及其他导致异常泌乳的疾病; (7)对已知研究药物成份过敏者。

Exclusion criteria:

(1) ovulation disorders or infertility caused by congenital physiological defects or malformations: (2) infertility caused by genetic factors; (3) Infertility caused by fallopian tube factors, or immune factors, or uterine fibroids, or myoadenosis, or endometriosis, or uterine dysplasia, confirmed by examination; (4) abnormal reproductive function of the spouse; (5) serious abnormalities of cardiovascular, liver, kidney or hematopoietic system; (6) Psychiatric diseases and other diseases that cause abnormal lactation; (7) Allergy to known investigational drug ingredients.

研究实施时间:

Study execute time:

From 2023-12-01

To      2024-09-30

征募观察对象时间:

Recruiting time:

From 2024-03-01

To      2024-06-30

干预措施:

Interventions:

组别:

试验组

样本量:

36

Group:

Experimental group

Sample size:

干预措施:

补肾促卵方和甲磺酸溴隐亭安慰剂

干预措施代码:

Intervention:

BushenCuluan fang And Bromocriptine mesylate placebo

Intervention code:

组别:

对照组

样本量:

36

Group:

Control group

Sample size:

干预措施:

甲磺酸溴隐亭片和补肾促卵方安慰剂

干预措施代码:

Intervention:

Bromocriptine mesylate tablets and BushenCuluan fang placebo

Intervention code:

样本总量 Total sample size : 72

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等

Institution/hospital:

Xiyuan Hospital, Chinese Academy of Traditional Chinese medicine

Level of the institution:

Class three, first class

测量指标:

Outcomes:

指标中文名:

凝血四项(FIB、APTT、TT、PT)

指标类型:

次要指标

Outcome:

Blood clotting (FIB, APTT, TT, PT)

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

血液

Measure time point of outcome:

Before and after treatment

Measure method:

Blood

指标中文名:

早卵泡期B超

指标类型:

次要指标

Outcome:

Early follicular stage B-ultrasound

Type:

Secondary indicator

测量时间点:

月经第2-4天

测量方法:

B超

Measure time point of outcome:

Menstruation 2-4 days

Measure method:

B-ultrasound

指标中文名:

抗苗勒管激素

指标类型:

次要指标

Outcome:

Anti-mullerian hormone(AMH)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑制素B

指标类型:

次要指标

Outcome:

INHB

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

性激素水平(FSH、 LH、 E2、P、T、PRL)

指标类型:

次要指标

Outcome:

Sex Hormone levels(FSH、 LH、 E2、P、T、PRL)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

安全性指标(血常规、尿常规、便常规、肝功能、肾功能、心电图)

指标类型:

副作用指标

Outcome:

Safety indicators (blood routine, urine routine, stool routine, liver function, kidney function, electrocardiogram)

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

Measure time point of outcome:

Before and after treatment

Measure method:

指标中文名:

排卵率

指标类型:

主要指标

Outcome:

Ovulation 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:

基础体温复常率

指标类型:

次要指标

Outcome:

Basal body temperature normalization 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:

排卵期B超

指标类型:

次要指标

Outcome:

Ovulatory B-ultrasound

Type:

Secondary indicator

测量时间点:

排卵期

测量方法:

B超

Measure time point of outcome:

Ovulatory period

Measure method:

B-ultrasound

指标中文名:

中医肾虚血瘀证证候积分

指标类型:

次要指标

Outcome:

integral of TCM kidney deficiency and blood stasis syndrome

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:

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:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 40
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):

随机数字表

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

Random number table

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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

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

No sharing

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:

一为病例记录表由课题组内研究人员填写; 数据管理由专人负责。

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

First, the case record form shall be filled in by researchers in the research group, and the data management shall be in the charge of special personnel.

数据管理委员会:

Data Managemen Committee:

Yes

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):

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