Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06047574

Collaborator

(none)

3,000

Enrollment

Location

22.4

Anticipated Duration (Months)

134.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: This study does not involve any interventions

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome

Anticipated Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jul 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
PCOS Oligomenorrhea/amenorrhea Clinical androgen excess or biochemical androgen excess Polycystic ovary showed by gynecological ultrasound	Other: This study does not involve any interventions This study does not involve any interventions
NOPCOS not meet Rotterdam standards	Other: This study does not involve any interventions This study does not involve any interventions

Arm

Intervention/Treatment

PCOS

Oligomenorrhea/amenorrhea Clinical androgen excess or biochemical androgen excess Polycystic ovary showed by gynecological ultrasound

Other: This study does not involve any interventions

This study does not involve any interventions

NOPCOS

not meet Rotterdam standards

Other: This study does not involve any interventions

This study does not involve any interventions

Outcome Measures

Primary Outcome Measures

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

body mass index ,BMI [baseline]
BMI=weight(kg)/height(m)^2
Waist/hip Ratio,WHR [baseline]
WHR=Waist Circumference(cm)/Hip Circumference(cm)
Number of menstruation in the last year [baseline]
physiological parameter,the total number of menstrual periods in the last year
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.
HOMA-IR [baseline]
Homeostatic model assessment insulin resistance index
TT [baseline]
total testosterone (nmol/L)
FT [baseline]
Free testosterone (nmol/L)
LH [baseline]
luteinizing hormone
FSH [baseline]
follicle-stimulating hormone
FBG [baseline]
fasting blood-glucose
PBG [baseline]
postprandial blood-glucose
FINS [baseline]
fasting serum insulin
PINS [baseline]
postprandial serum insulin
AST [baseline]
aspartate aminotransferase
ALT [baseline]
alanine aminotransferase
UA [baseline]
Uric acid
CR [baseline]
Creatinine
LDL-c [baseline]
low-density lipoprotein cholesterol
HDL-c [baseline]
high-density lipoprotein cholesterol
TC [baseline]
Total Cholesterol (mmol/L)
TG [baseline]
Triglyceride (mmol/L)
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.
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.
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.
Chemerin [baseline]
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
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.
RBP-4 [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）
SHBG [baseline]
sex hormone-binding globulin (nmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.