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

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: This study does not involve any interventions

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Manna Zhang, Dr; Phone Number: （86）66301004; Email: mannazhang@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Recruiting
      • Shanghai Tenth People' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Polycystic ovary syndrome (PCOS) is a common dis-order in women that is characterized by hyperandro-genism (that is, evidence of excess male hormone or androgen effect; clinically, such as hirsut-ism, and/or biochemically, such as hyperandrogen aemia or excess levels of androgen), ovulatory dysfunction (including menstrual dysfunction) and polycystic ovarian morphology (PCOM; an excessive number of preantral follicles in the ovaries).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Shen Qu, Dr, Shang hai Tenth People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Polycystic Ovary Syndrome; clinical characteristics; new biomarkers
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: Clinical Characteristics PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No