Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Other: This study does not involve any interventions
- Registration Number
- NCT06047574
- Lead Sponsor
- Shanghai 10th People's Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 3000
- Female aged 18- 45;
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PCOS This study does not involve any interventions 1. Oligomenorrhea/amenorrhea 2. Clinical androgen excess or biochemical androgen excess 3. Polycystic ovary showed by gynecological ultrasound NOPCOS This study does not involve any interventions not meet Rotterdam standards
- Primary Outcome Measures
Name Time Method Fibrinogen-like-protein 1 (FGL1) baseline 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.
- Secondary Outcome Measures
Name Time Method Waist/hip Ratio,WHR baseline WHR=Waist Circumference(cm)/Hip Circumference(cm)
Ferriman-Gallwey score Time Frame: baseline 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.
Number of menstruation in the last year baseline physiological parameter,the total number of menstrual periods in the last year
TT baseline total testosterone (nmol/L)
LH baseline luteinizing hormone
FT baseline Free testosterone (nmol/L)
AST baseline aspartate aminotransferase
CR baseline Creatinine
LDL-c baseline low-density lipoprotein cholesterol
HDL-c baseline high-density lipoprotein cholesterol
Chemerin baseline A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
RBP-4 baseline A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
body mass index ,BMI baseline BMI=weight(kg)/height(m)\^2
PBG baseline postprandial blood-glucose
SHBG baseline sex hormone-binding globulin (nmol/L)
HOMA-IR baseline Homeostatic model assessment insulin resistance index
Interleukin 22#IL-22 baseline 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.
omentin-1 baseline A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
leptin baseline A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
adiponectin baseline A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.
DHEAS baseline dehydroepiandrosterone（nmol/L）
FSH baseline follicle-stimulating hormone
FINS baseline fasting serum insulin
PINS baseline postprandial serum insulin
ALT baseline alanine aminotransferase
UA baseline Uric acid
TG baseline Triglyceride (mmol/L)
Tumor Necrosis Factor# TNF baseline 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.
FBG baseline fasting blood-glucose
TC baseline Total Cholesterol (mmol/L)
Interleukin 6#IL-6 baseline 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.
Interleukin 8# IL-8 baseline 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.
Trial Locations
- Locations (1)
Department of Endocrinology, Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China