Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients With 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 in this study, used statistical software such as SPSS for data analysis, and used experimental techniques such as ELISA to detect serum samples, aiming to explore the relationship between the body anthropometry, glucose and lipid metabolism, gonadal hormones and body fat distribution in patients with polycystic ovary syndrome and to discovery new biomarkers and promote the realization of more accurate personalized medicine.

Official Title
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Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients With 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; Meet Rotterdam criteria; Exclusion Criteria: Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times of the upper limit of normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.

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 |
| --- | --- | --- |
| diagnostic markers of PCOS patients | 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. | baseline | 
| HOMA-IR | Homeostatic model assessment insulin resistance index | baseline | 
| TT | total testosterone (nmol/L) | baseline | 
| FT | Free testosterone (nmol/L) | baseline | 
| SHBG | SHBG (nmol/L) | baseline | 
| LH | luteinizing hormone | baseline | 
| FSH | follicle-stimulating hormone | baseline | 
| DHEAS | dehydroepiandrosterone | 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 | 
| resistin | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| Visfatin | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| Apelin | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | baseline | 
| Vaspin. | A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function. | 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