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Based on the follicle-granulosa cell metabolic pathway to explore the effects of zaoshi-phlegm-reducing Traditional Chinese medicine on the developmental potential and energy metabolism of phlegm-dampness

注册号：

Registration number：

ITMCTR2100005340

最近更新日期：

Date of Last Refreshed on：

2021-11-27

注册时间：

Date of Registration：

2021-11-27

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于卵泡液-颗粒细胞代谢路径探讨燥湿化痰中药对痰湿型PCOS卵母发育潜能及能量代谢的影响

Public title：

Based on the follicle-granulosa cell metabolic pathway to explore the effects of zaoshi-phlegm-reducing Traditional Chinese medicine on the developmental potential and energy metabolism of phlegm-dampness

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于卵泡液-颗粒细胞代谢路径探讨燥湿化痰中药对痰湿型PCOS卵母发育潜能及能量代谢的影响

Scientific title：

Based on the follicle-granulosa cell metabolic pathway to explore the effects of zaoshi-phlegm-reducing Traditional Chinese medicine on the developmental potential and energy metabolism of phlegm-dampness

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：

ChiCTR2100053691 ; ChiMCTR2100005340

申请注册联系人：

赵帅

研究负责人：

赵帅

Applicant：

shuai zhao

Study leader：

shuai zhao

申请注册联系人电话：

Applicant telephone：

053168617766

研究负责人电话：

Study leader's telephone：

053168617766

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：

xiao-xue0531@163.com

研究负责人电子邮件：

Study leader's E-mail：

xiao-xue0531@163.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 Xi Road, Lixia District, Jinan City

Study leader's address：

42 Wenhua Xi Road, Lixia District, Jinan City

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：

山东中医药大学附属医院

Applicant's institution：

Affiliated Hospital of Shandong University 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：

AF/SC-08/02.0

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

山东中医药大学附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2021/2/28 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：

山东中医药大学附属医院

Primary sponsor：

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

42 Wenhua Xi Road, Lixia District, Jinan City

Primary sponsor's address：

42 Wenhua Xi Road, Lixia District, Jinan City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

Shandong Province

市(区县)：

JINAN

Country：

CHINA

Province：

Shandong Province

City：

JINAN

单位(医院)：

山东中医药大学附属医院

具体地址：

42 Wenhua Xi Road, Lixia District, Jinan City

Institution
hospital：

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address：

42 Wenhua Xi Road, Lixia District, Jinan City

经费或物资来源：

国家自然基金课题

Source(s) of funding：

42 Wenhua Xi Road, Lixia District, Jinan City

研究疾病：

多囊卵巢综合征

研究疾病代码：

Target disease：

polycystic ovarian syndrome

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

病例对照研究

Case-Control study

研究所处阶段：

Study phase：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

本课题以挖掘“燥湿化痰促生殖”理论的科学内涵为目标，以苍附导痰汤与现代辅助生殖技术相结合，通过对痰湿型PCOS患者卵泡液-颗粒细胞进行代谢路径分析，卵泡液-颗粒细胞线粒体CXCL5/STAT3/SOCS2的检测，从形态动能、分子蛋白及细胞水平分析其对卵母细胞、胚胎发育及体外受精-胚胎移植结局的影响。以期确定中医证候的内在分子机制，为中医证候的客观化提供代谢路径水平的科学依据，为多层次丰富发展“燥湿化痰促生殖”理论提供科学依据，为中医药在人类生殖医学发展中的应用提供更可靠的依据及新的思路

Objectives of Study：

This project aims at exploring the scientific connotation of the theory of "dampness disperses phlegm and promotes reproduction", combining Cangfu Phlegm Guide Decoction with modern assisted reproduction technology, through analyzing the metabolic path of follicle-granulosa cells of patients with phlegm-dampness PCOS, and detecting CXCL5/STAT3/SOCS2 of follicle-granulosa cells mitochondria. The effects on oocyte, embryo development and in vitro fertilization-embryo transfer were analyzed at the morphological kinetic energy, molecular protein and cellular levels. In order to determine the internal molecular mechanism of TCM syndromes, provide scientific basis for the objectification of TCM syndromes, provide scientific basis for the multi-level development of the theory of "dryness and dampness reducing phlegm promoting reproduction", and provide more reliable basis and new ideas for the application of TCM in the development of human reproductive medicine

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

年龄在35-45岁已婚妇女；符合本病西医诊断及中医痰湿证辨证标准。 多囊卵巢综合征诊断标准： 中华医学会妇产科分会妇科内分泌学组制定了2011 “中国PCOS诊断标准”：闭经或月经稀发或不规则子宫出血是必备标准，再具备以下至少1项，可诊断为疑似PCOS：高雄激素的临床表现或高雄激素血症；超声提示多囊卵巢（至少一侧卵巢内直径0.2-0.9cm的卵泡数超过12枚，或卵巢体积大于等于10cm3）。疑似PCOS患者必须除外其他可能引发排卵障碍和高雄激素的疾病才能确诊。中国PCOS诊断标准与国际标准比较，更强调卵巢功能障碍的病理作用，且更加贴合中国女性的实际情况。 痰湿型多囊卵巢综合征辨证：参照《中华人民共和国中医药行业标准—中医病症诊断疗效标准》以及全国统编教材《中医妇科学》第七版制定。 主证：①婚久不孕；②月经后期，或渐至闭经；③月经量少，色淡红。 兼症：①形体肥胖；②胸闷呕恶；③带下量多粘腻；④大便易溏或经行泄泻。 舌脉：舌淡苔白腻，脉滑尺弱。 以上主证三项必备，具备1-2项兼证即可诊断，舌脉为参。

Inclusion criteria

Married women aged 35-45; This disease conforms to western medicine diagnosis and Chinese medicine phlegm-dampness syndrome differentiation standard. Diagnostic criteria of polycystic ovary syndrome: The Gynecological Endocrinology Group of The Chinese Society of Obstetrics and Gynecology formulated the 2011 "Chinese DIAGNOSTIC Criteria for PCOS" : amenorrhea, sporadic menstruation or irregular uterine bleeding are the necessary criteria. Suspected PCOS can be diagnosed with at least one of the following: clinical manifestations of hyperandrogen or hyperandrogenemia; Ultrasound suggests polycystic ovaries (at least one ovary has more than 12 follicles 0.2 -- 0.9cm in diameter, or an ovarian volume greater than or equal to 10cm3). Suspected PCOS patients must be excluded from other conditions that may cause ovulation disorders and high androgen levels. Compared with international standards, Chinese PCOS diagnostic criteria emphasize more on the pathological role of ovarian dysfunction and are more suitable for the actual situation of Chinese women. Syndrome differentiation of phlegm-dampness polycystic ovary syndrome: formulated with reference to the "Chinese Medicine Industry standard of the People's Republic of China - Standard of Diagnosis and Efficacy of Chinese Medicine Diseases" and the seventh edition of the national unified textbook "Gynecology of Chinese Medicine". Main syndrome: ① long marriage infertility; ② Late menstruation, or gradually to amenorrhea; ③ Less menstruation, light red color. And disease: ① body fat; (2) chest nausea; (3) the amount of sticky belt; ④ Loose stool or diarrhea through menstruation. Tongue pulse: the tongue is pale and white and greasy with moss, and the pulse is slippery and weak. The above three main syndromes are necessary, and one or two concurrent syndromes can be diagnosed, with tongue pulse as reference.

排除标准：

肾上腺、甲状腺、垂体等内分泌功能异常的患者，如肾上腺皮质增生症、肾上腺皮质功能减退、甲亢、甲低、垂体肿瘤、席汉氏综合征、糖尿病等；心脑血管疾病患者，如高血压、冠心病等；肝肾疾病患者；神经、精神疾病患者；血液病患者；急性生殖泌尿系统炎症患者；生殖系统肿瘤患者；生殖器官器质性病变者；三个月内服用避孕药或其他含有激素类药物的患者；生理性月经后期及闭经者；依从性较差的患者。

Exclusion criteria：

Patients with abnormal adrenal, thyroid and pituitary endocrine functions, such as adrenal cortical hyperplasia, adrenal cortical hypofunction, hyperthyroidism, hypothyroidism, pituitary tumor, Sheehan's syndrome, diabetes, etc. Patients with cardiovascular and cerebrovascular diseases, such as hypertension and coronary heart disease; Patients with liver and kidney diseases; Patients with neurological or mental diseases; Patients with blood diseases; Patients with acute genitourinary inflammation; Patients with reproductive system tumors; Organic diseases of reproductive organs; Patients who take birth control pills or other hormone-containing drugs within three months; Physiologic late menstruation and amenorrhea; Patients with poor compliance.

研究实施时间：

Study execute time：

从From 2022-01-01

至To      2024-12-31

征募观察对象时间：

Recruiting time：

从From 2022-01-01

至To      2023-12-01

干预措施：

Interventions：

组别：

4

样本量：

60

Group：

four

Sample size：

干预措施：

颗粒

干预措施代码：

Intervention：

particles

Intervention code：

样本总量 Total sample size ： 240

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 Province

City：

Ji'nan

单位(医院)：

山东中医药大学附属医院

单位级别：

三级甲等

Institution/hospital：

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

卵母细胞质量

指标类型：

主要指标

Outcome：

Oocyte mass

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：

颗粒细胞

Sample Name：

follicular Fluid

Tissue：

granule cells

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 35 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）：

选取于我院生殖与遗传中心行体外受精-胚胎移植术且符合纳入标准的痰湿型多囊卵巢综合征不孕患者120例，按照随机数字表法分为实验组与对照组1，每组各60例；另选取非痰湿型多囊卵巢综合征患者60例作为对照组2，以及因男方因素行IVF的正常女性60例为对照组3。取卵日留取患者卵泡液-颗粒细胞作为研究对象。受试者需经医院伦理委员会批准，并签署知情同意书。

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

A total of 120 infertility patients with phlegm-wet polycystic ovary syndrome who underwent in vitro fertilization-embryo transfer in the Reproductive and Genetic Center of our hospital and met the inclusion criteria were selected and divided into experimental group and control group 1 according to random number ta

盲法：

Blinding：

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）：

课题完成后

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

After the project is completed

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：

病例记录表和电子采集表

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

Case record form and electronic collection form

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):

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