Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Study Overview
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Brief Summary
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The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to promote the realization of more accurate personalized medicine.

Official Title
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Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: This study does not involve any interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged 18- 45; Exclusion Criteria: Female patients younger than 18 years old or older than 45 years old; Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction; Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism; Abnormal liver or renal function((≥ 3 times of the upper limit of normal range) Type 1 diabetes, single gene mutation diabetes, or pancreatic damage Diabetes or other secondary diabetes caused by diabetes; History of malignant tumors; Severe infection, severe anemia, neutropenia and other systemic chronic diseases; Undergo total hysterectomy or ovarian adnexectomy; Mental illness, dementia or other cognitive behavioral problems; Use hypoglycemic drugs that may affect insulin resistance and androgen levels in the last 3 months, including thiazolidinediones, metformin, SGLT-2, and acarbose and GLP-1RA and other drugs; Use letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, anti-androgens (spironolactone, Cyproterone acetate, flutamide, etc.) and other drugs for the treatment of PCOS.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS<br>Oligomenorrhea/amenorrhea Clinical androgen excess or biochemical androgen excess Polycystic ovary showed by gynecological ultrasound | Other: This study does not involve any interventions<br>* This study does not involve any interventions<br>|
| NOPCOS<br>not meet Rotterdam standards | Other: This study does not involve any interventions<br>* This study does not involve any interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrinogen-like-protein 1 (FGL1) | Fibrinogen-like-protein 1 (FGL1), is a novel hepatokine that plays an important role in hepatic steatosis, insulin resistance and obesity. There is no maximum or minimum value for this parameter and the higher scores mean a worse outcome. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index ,BMI | BMI=weight(kg)/height(m)^2 | baseline | 
| Waist/hip Ratio,WHR | WHR=Waist Circumference(cm)/Hip Circumference(cm) | baseline | 
| Number of menstruation in the last year | physiological parameter,the total number of menstrual periods in the last year | baseline | 
| Ferriman-Gallwey score | The minimum value of Ferriman-Gallwey score is 0 and the maximum value is 44. An Ferriman-Gallwey score greater than or equal to 6 is considered to be a clinical manifestation of androgen excess. | Time Frame: baseline | 
| HOMA-IR | Homeostatic model assessment insulin resistance index | baseline | 
| TT | total testosterone (nmol/L) | baseline | 
| FT | Free testosterone (nmol/L) | baseline | 
| LH | luteinizing hormone | baseline | 
| FSH | follicle-stimulating hormone | baseline | 
| FBG | fasting blood-glucose | baseline | 
| PBG | postprandial blood-glucose | baseline | 
| FINS | fasting serum insulin | baseline | 
| PINS | postprandial serum insulin | baseline | 
| AST | aspartate aminotransferase | baseline | 
| ALT | alanine aminotransferase | baseline | 
| UA | Uric acid | baseline | 
| CR | Creatinine | baseline | 
| LDL-c | low-density lipoprotein cholesterol | baseline | 
| HDL-c | high-density lipoprotein cholesterol | baseline | 
| TC | Total Cholesterol (mmol/L) | baseline | 
| TG | Triglyceride (mmol/L) | baseline | 
| Interleukin 22#IL-22 | The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome. | baseline | 
| Interleukin 6#IL-6 | IL-6. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome. | baseline | 
| Interleukin 8# IL-8 | The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome. | baseline | 
| Tumor Necrosis Factor# TNF | The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome. | baseline | 
| Chemerin | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| omentin-1 | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| leptin | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| RBP-4 | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| adiponectin | A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| DHEAS | dehydroepiandrosterone（nmol/L） | baseline | 
| SHBG | sex hormone-binding globulin (nmol/L) | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Clinical characteristics, New biomarkers, Multidisciplinary