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Study for the Mechanism of Cangfu Dutan decoction in the treatment of phlegm-dampness PCOS Infertility from the Perspective of Lipid Metabolism

注册号：

Registration number：

ITMCTR1900002388

最近更新日期：

Date of Last Refreshed on：

2019-06-08

注册时间：

Date of Registration：

2019-06-08

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

从脂代谢角度探讨苍附导痰汤治疗痰湿型PCOS不孕患者的作用机制

Public title：

Study for the Mechanism of Cangfu Dutan decoction in the treatment of phlegm-dampness PCOS Infertility from the Perspective of Lipid Metabolism

注册题目简写：

English Acronym：

研究课题的正式科学名称：

从脂代谢角度探讨苍附导痰汤治疗痰湿型PCOS不孕患者的作用机制

Scientific title：

Study for the Mechanism of Cangfu Dutan decoction in the treatment of phlegm-dampness PCOS Infertility from the Perspective of Lipid Metabolism

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：

ChiCTR1900023712 ; ChiMCTR1900002388

申请注册联系人：

张海燕

研究负责人：

张海燕

Applicant：

Haiyan Zhang

Study leader：

Haiyan Zhang

申请注册联系人电话：

Applicant telephone：

+86 156228967606

研究负责人电话：

Study leader's telephone：

+86 15628967606

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：

530319196@qq.com

研究负责人电子邮件：

Study leader's E-mail：

530319196@qq.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：

山东省济南市历下区文化西路42号

研究负责人通讯地址：

山东省济南市历下区文化西路42号

Applicant address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, China

Study leader's address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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：

山东中医药大学

Applicant's institution：

Shandong Hospital 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：

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：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 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：

山东中医药大学

Primary sponsor：

Shandong Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

山东省济南市历下区文化西路42号

Primary sponsor's address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, 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)：

山东省

市(区县)：

济南市

Country：

China

Province：

Shandong

City：

Ji'nan

单位(医院)：

山东省中医院

具体地址：

山东省济南市历下区文化西路42号

Institution
hospital：

Shandong Hospital of Traditional Chinese Medicine

Address：

42 Wenhua Road West, Lixia District, Ji'nan, Shandong, China

经费或物资来源：

研究生经费

Source(s) of funding：

Graduate fund

研究疾病：

多囊卵巢综合征

研究疾病代码：

Target disease：

Polycystic ovary syndrome

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：

以苍附导痰汤与现代辅助生殖技术相结合，治疗痰湿型多囊卵巢综合症患者，设计对照组进行对比，监测血清内分泌FSH、LH、T、以及卵泡液内脂素、亚油酸表达水平，从脂代谢角度探讨苍附导痰汤改善痰湿型多囊卵巢综合症患者临床症状体征、提高卵细胞质量，调节排卵功能，改善 IVF-ET妊娠结局的作用机制。

Objectives of Study：

The patients with phlegm-dampness polycystic ovary syndrome were treated with Cangfu Dutan decoction combined with modern assisted reproductive technology. The control group was designed and compared. The levels of serum endocrine FSH, LH, T, and the expression of lipopolysaccharide and linoleic acid in follicular fluid were monitored. From the point of view of lipid metabolism, this paper discusses the mechanism of Cangfu Dutan decoction in improving clinical symptoms and signs, improving egg quality, regulating ovulatory function and improving pregnancy outcome in patients with phlegm-dampness polycystic ovary syndrome (IVF-ET).

药物成份或治疗方案详述：

选择76例中医诊断属痰湿型拟行体外受精-胚胎移植（IVF-ET）的多囊卵巢综合征患者，按照随机数字表法均分为实验组(苍附导痰汤+IVF)38例、观察组(安慰剂+IVF)38例，另选取PCOS非痰湿型患38例(安慰剂+IVF)为对照组。三组者皆采用GnRH-a+达英-35双降方案，中药组患者于服用达英-35同时予苍附导痰汤方，直至HCG注射日。对照组患者给以安慰剂颗粒，使用方法同上。在治疗前及治疗1个月后将对实验组与观察组治疗前后痰湿症候积分变化进行比较，测定血清内分泌、以及血清及卵泡液内脂素、亚油酸水平，三组患者HCG注射日血E2、LH、P水平；计算体重指数 ,、腹围、胸围，获卵数、受精率、2PN卵裂率、优质胚胎率、临床妊娠率。

Description for medicine or protocol of treatment in detail：

76 patients with polycystic ovary syndrome (PCOS) diagnosed by traditional Chinese medicine (TCM) were randomly divided into experimental group (Cangfu Dutan decoction + IVF) and observation group (placebo + IVF). According to the method of random number table, there were 38 cases in the experimental group (Cangfu Dutan decoction + IVF) and 38 cases in the observation group (placebo + IVF). In addition, 38 patients with non-phlegm-dampness type of PCOS (placebo + IVF) were selected as control group. The patients in the traditional Chinese medicine group were given Cangfu Dutan decoction at the same time until the day of HCG injection. All the patients in the three groups were treated with GnRH-a+ Daying-35, and the patients in the traditional Chinese medicine group were given Cangfu Dutan decoction at the same time. The patients in the control group were given placebo granules, and the method of use was the same as above. Before treatment and 1 month after treatment, the changes of phlegm-dampness syndrome score before and after treatment in the experimental group and the observation group were compared, and the levels of serum endocrine, adiponectin and linoleic acid in serum and follicular fluid were measured. The levels of E2, LH and P on the day of HCG injection were calculated, and the body mass index, abdominal circumference, chest circumference, number of eggs obtained, fertilization rate, 2PN cleavage rate, high quality embryo rate and clinical pregnancy rate were calculated.

纳入标准：

1.纳入标准 1.1痰湿证PCOS组（实验组、观察组） (1)符合＜35岁年龄标准； (2)符合多PCOS及不孕症、脾虚痰湿证候诊断标准； (3)生殖器官解剖结构未见异常； (4)男方精液水平大致正常； (5)签署知情同意书。 1.2非痰湿证PCOS组（对照组） 符合PCOS及不孕症诊断标准，不符合脾虚痰湿证候诊断标准；余标准与痰湿证PCOS组相同。

Inclusion criteria

1. Inclusion criteria. 1.1 phlegm-dampness syndrome PCOS group (experimental group, observation group). (1) meeting the age standard of < 35 years old; (2) it meets the diagnostic criteria of multi-PCOS, sterility, spleen deficiency and phlegm-dampness syndrome; (3) there was no abnormality in the anatomical structure of reproductive organs;(4) the semen level of male was about normal; (5) sign the informed consent form. 1.2 non-phlegm-dampness syndrome PCOS group (control group). It met the diagnostic criteria of PCOS and sterility, but not the diagnostic criteria of spleen deficiency and phlegm-dampness syndrome, and the other criteria were the same as those of phlegm-dampness syndrome PCOS group.

排除标准：

排除标准 (1)治疗前3个月曾使用任何影响人体激素、糖脂代谢水平类药物者； (2)患有严重精神疾病患者； (3)患有下丘脑、垂体、高催乳素血症、甲状腺疾病等疾病者； (4)夫妇外周血染色体异常者； (5)信息资料不完整的患者。

Exclusion criteria：

Exclusion standard. (1) those who had used any drugs that affected the level of hormone, glucose and lipid metabolism in human body 3 months before treatment;(2) patients with severe mental illness;(3) patients with hypothalamic, pituitary, hyperprolactinemia, thyroid diseases and other diseases;(4) abnormal chromosome in peripheral blood of husband and wife; (5) patients with incomplete information.

研究实施时间：

Study execute time：

从From 2018-03-01

至To      2020-05-15

征募观察对象时间：

Recruiting time：

从From 2018-03-01

至To      2021-02-28

干预措施：

Interventions：

组别：

痰湿型Group 1

样本量：

38

Group：

phlegm-dampness syndrome PCOS Group 1 (randomly allocation)

Sample size：

干预措施：

苍附导痰汤+IVF

干预措施代码：

Intervention：

Cangfu Dutan decoction combined with modern assisted reproductive technology

Intervention code：

组别：

Group 2

样本量：

38

Group：

phlegm-dampness syndrome PCOS Group 2 (random allocation)

Sample size：

干预措施：

苍附导痰汤安慰剂+IVF

干预措施代码：

Intervention：

Placebo of the Cangfu Dutan decoction combined with modern assisted reproductive technology

Intervention code：

组别：

Group 3 (不随机分组）

样本量：

38

Group：

Group 3 (not randomization)

Sample size：

干预措施：

中药干预

干预措施代码：

Intervention：

Traditional Chinese medicine intervention

Intervention code：

样本总量 Total sample size ： 114

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

山东省

市(区县)：

济南市

Country：

China

Province：

Shandong

City：

Ji'nan

单位(医院)：

山东省中医院

单位级别：

三甲医院

Institution/hospital：

Shandong Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

黄体生成素

指标类型：

次要指标

Outcome：

Luteinizing hormone

Type：

Secondary indicator

测量时间点：

扳机日

测量方法：

酶联免疫法

Measure time point of outcome：

Trigger day

Measure method：

Elisa

指标中文名：

雌激素

指标类型：

次要指标

Outcome：

estradiol

Type：

Secondary indicator

测量时间点：

扳机日

测量方法：

酶联免疫法

Measure time point of outcome：

Trigger day

Measure method：

Elisa

指标中文名：

游离脂肪酸

指标类型：

主要指标

Outcome：

Free fatty acid

Type：

Primary indicator

测量时间点：

取卵日

测量方法：

酶联免疫法

Measure time point of outcome：

The date of follicular retrieval

Measure method：

Elisa

指标中文名：

内脂素

指标类型：

主要指标

Outcome：

visfatin

Type：

Primary indicator

测量时间点：

取卵日

测量方法：

酶联免疫法

Measure time point of outcome：

The date of follicular retrieval

Measure method：

Elisa

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

血液

Sample Name：

blood

Tissue：

blood

人体标本去向

使用后销毁

说明

2年

Fate of sample 

Destruction after use

Note：

2 years

标本中文名：

卵泡液

组织：

卵巢

Sample Name：

Follicular fluid

Tissue：

ovary

人体标本去向

使用后销毁

说明

2年

Fate of sample 

Destruction after use

Note：

2 years

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 20 岁
Min age years
最大 45 岁
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）：

按照完全随机数字表法将76例痰湿型PCOS IVF患者分为实验组（苍附导痰汤颗粒）与观察组(安慰剂），每组38例；PCOS非痰湿组38例为对照组。

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

According to the completely random number table method, 76 patients with phlegm-dampness PCOS IVF were divided into experimental group (Cangfu Dutan decoction granule) and observation group (placebo), 38 cases in each group, and 38 cases in PCOS non-phlegm dampness group as control group.

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

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）：

2020年12月31日 中国知网 http://www.cnki.net/

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

December 31, 2020 China knowledge net http://www.cnki.net/

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

数据管理委员会：

Data Managemen Committee：

有

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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