研究疾病:
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多囊卵巢综合征
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研究疾病代码:
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Target disease:
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polycystic ovarian syndrome
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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主要目的:本项目通过分析痰湿型 PCOS、非痰湿型 PCOS 受试者与因男方因素行试管婴儿的正常女性取卵日血清及卵泡液中免疫细胞亚群种类的变化, 阐明痰湿型 PCOS 所引起的重要免疫调控机制,病证结合,从免疫组学的角度发展中医证候客观化;并应用经典燥湿化痰方药干预,以方测证,揭示中药疗效产生的免疫微环境的变化。
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Objectives of Study:
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Main purpose: By analyzing the changes of immune cell subsets in serum and follicular fluid of subjects with phlegm-dampness PCOS, non-phlegm-dampness PCOS and normal women who underwent IVF due to male factors on the day of egg collection, this project clarified the important immune regulation mechanism caused by phlegm-dampness PCOS, combined disease and syndrome, and developed the objectivity of TCM syndromes from the perspective of immunogenetics; the classic dryness, dampness and phlegm removing formula were used to intervene and the changes of immune microenvironment caused by the effect of traditional Chinese medicine were revealed.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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痰湿型 PCOS 不孕受试者:
1.多囊卵巢综合征诊断标准:
参照 2018 年中华医学会妇产科学分会内分泌学组制定的《多囊卵巢综合征中国诊疗指南》制定:
(1)月经稀发或闭经或不规则子宫出血;
(2)高雄激素临床表现或高雄激素血症;
(3)超声下表现为多囊卵巢样形态。
以上具备(1),符合(2)(3)中的一项,且排除库欣综合征、非经典型先天性肾上腺皮质增生、卵巢或肾上腺分泌雄激素的肿瘤等可能引起高雄激素的疾病和功能 性下丘脑性闭经等引起排卵异常的疾病。
2.痰湿证中医辩证标准: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。入选病人至少由三位中医妇科学高级职称专家进行独立辩证,结论一致者方可纳入。
主症:
(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。
3.符合多囊卵巢综合征诊断标准及痰湿证中医辨证标准,且具备以下条件:
(1)年龄<40 岁;
(2)婚后同居一年以上,性生活正常,未避孕未孕;
(3)男方精液常规检查大致正常。
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Inclusion criteria
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Phlegm-dampness PCOS infertile subjects
1. Diagnostic criteria for polycystic ovary syndrome: according to the Guidelines for the Diagnosis and Treatment of Polycystic ovary syndrome in China formulated by the Endocrinology Group of the Chinese Society of Obstetrics and Gynecology in 2018:
(1) Periphery menstruation or amenorrhea or irregular uterine bleeding;
(2) Clinical manifestations of hyperandrogen or hyperandrogenemia;
(3) The ultrasonography showed polycystic ovary like morphology.
The above mentioned conditions are (1), in line with one of (2)(3), and exclude diseases that may cause hyperandrogen, such as Cushing's syndrome, atypical congenital adrenal hyperplasia, androgen-secreting tumors of ovary or adrenal gland, and diseases that may cause abnormal ovulation, such as functional hypothalamic amenorrhea.
2. Traditional Chinese medicine dialectical standards for phlegm and dampness syndrome: formulated with reference to the Traditional Chinese Medicine Industry Standards of the People's Republic of China -- Standards for Diagnosis and Efficacy of Diseases of Traditional Chinese Medicine and the seventh edition of the national textbook Traditional Chinese Gynecology. At least three experts with senior title of TCM gynecology conducted independent dialectical analysis on the selected patients, and the conclusion conforming ones could be included.
Main signs:
(1) Long marriage infertility;
(2) Menstrual period, or gradually to amenorrhea;
(3) Less menstrual volume, light red color.
Concurrent disease:
(1) Body obesity;
(2) Chest tightness nausea;
(3) With the amount of sticky;
(4) Loose stools or diarrhea through diarrhea. Tongue pulse: the tongue is pale and greasy with white moss, and the pulse is slippery and weak.
The above three main syndromes are necessary. With 1-2 concurrent syndromes, the diagnosis can be made. Tongue pulse is the reference.
3. Meet the diagnostic criteria of polycystic ovary syndrome and TCM syndrome differentiation criteria of phlegm and dampness syndrome, and have the following items:
(1) Aged < 40 years;
(2) Cohabitation after marriage for more than one year, normal sexual life, no contraception and no pregnancy;
(3) Outine semen examination of the man was generally normal.
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排除标准:
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1.生殖系统畸形或严重全身性疾病不能承受妊娠者;
2.患有严重的精神疾病,或性传播疾病,或染色体异常导致的不孕;
3.急性生殖系统疾病感染期,或接触致畸量的射线、毒物,并处于作用期;
4.患有子宫内膜异位症、高泌乳素血症等其他疾病导致的不孕;
5.未按规定用药或依从性欠佳者。
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Exclusion criteria:
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1. Reproductive system malformation or serious systemic diseases can not bear pregnancy;
2. Severe mental illness, or sexually transmitted diseases, or chromosomal abnormalities resulting in infertility;
3. Acute reproductive system disease infection stage, or exposure to teratogenic radiation, poison, and in the action stage;
4. Infertility caused by endometriosis, hyperprolactinemia and other diseases;
5. Do not take drugs according to the regulations or have poor compliance.
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研究实施时间:
Study execute time:
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从From
2021-06-01
至To
2023-06-30
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征募观察对象时间:
Recruiting time:
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从From
2021-06-01
至To
2022-06-30
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