Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: This study does not involve any interventions

• Registration Number: NCT05063383
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-10-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NOPCOS	This study does not involve any interventions	not meet Rotterdam standards
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

Primary Outcome Measures

Name	Time	Method
diagnostic markers of PCOS patients	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
body mass index ,BMI	baseline	BMI=weight(kg)/height(m)\^2
Number of menstruation in the last year	baseline	physiological parameter,the total number of menstrual periods in the last year
DHEAS	baseline	dehydroepiandrosterone
PINS,	baseline	postprandial serum insulin
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.
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.
HOMA-IR	baseline	Homeostatic model assessment insulin resistance index
TT	baseline	total testosterone (nmol/L)
FT	baseline	Free testosterone (nmol/L)
SHBG	baseline	SHBG (nmol/L)
ALT	baseline	alanine aminotransferase
CR	baseline	Creatinine
HDL-c	baseline	high-density lipoprotein cholesterol
LH	baseline	luteinizing hormone
FBG	baseline	fasting blood-glucose;
AST	baseline	aspartate aminotransferase
LDL-c	baseline	low-density lipoprotein cholesterol
TG	baseline	Triglyceride (mmol/L)
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.
Apelin	baseline	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Waist/hip Ratio,WHR	baseline	WHR=Waist Circumference(cm)/Hip Circumference(cm)
Ferriman-Gallwey score	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.
PBG	baseline	postprandial blood-glucose
FINS	baseline	fasting serum insulin
UA	baseline	Uric acid
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.
leptin	baseline	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
resistin	baseline	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Visfatin	baseline	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Vaspin.	baseline	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
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 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.
FSH	baseline	follicle-stimulating hormone

Trial Locations

Locations (1)

Shanghai Tenth People' Hospital; 🇨🇳 Shanghai, Shanghai, China