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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05063383
Enrollment
600
Registered
2021-10-01
Start date
2019-01-01
Completion date
2025-12-30
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome, clinical characteristics, new biomarkers

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.

Interventions

This study does not involve any interventions

Sponsors

Shanghai 10th People's Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
diagnostic markers of PCOS patientsbaselineFibrinogen-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

MeasureTime frameDescription
Waist/hip Ratio,WHRbaselineWHR=Waist Circumference(cm)/Hip Circumference(cm)
Number of menstruation in the last yearbaselinephysiological parameter,the total number of menstrual periods in the last year
Ferriman-Gallwey scorebaselineThe 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-IRbaselineHomeostatic model assessment insulin resistance index
TTbaselinetotal testosterone (nmol/L)
FTbaselineFree testosterone (nmol/L)
SHBGbaselineSHBG (nmol/L)
LHbaselineluteinizing hormone
FSHbaselinefollicle-stimulating hormone
DHEASbaselinedehydroepiandrosterone
FBGbaselinefasting blood-glucose;
PBGbaselinepostprandial blood-glucose
FINSbaselinefasting serum insulin
PINS,baselinepostprandial serum insulin
ASTbaselineaspartate aminotransferase
ALTbaselinealanine aminotransferase
UAbaselineUric acid
body mass index ,BMIbaselineBMI=weight(kg)/height(m)\^2
LDL-cbaselinelow-density lipoprotein cholesterol
HDL-cbaselinehigh-density lipoprotein cholesterol
TCbaselineTotal Cholesterol (mmol/L)
TGbaselineTriglyceride (mmol/L)
Interleukin 22,IL-22baselineThe 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-6baselineIL-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-8baselineThe 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, TNFbaselineThe 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.
ChemerinbaselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
omentin-1baselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
leptinbaselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
RBP-4baselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
adiponectinbaselineA adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.
resistinbaselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
VisfatinbaselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
ApelinbaselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Vaspin.baselineA adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
CRbaselineCreatinine

Countries

China

Contacts

Primary ContactManna Zhang, Dr
mannazhang@126.com(86)66301004

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026