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Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06047574
Enrollment
3000
Registered
2023-09-21
Start date
2023-09-18
Completion date
2026-07-30
Last updated
2026-03-09

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, Multidisciplinary

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.

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;

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.

Design outcomes

Primary

MeasureTime frameDescription
Fibrinogen-like-protein 1 (FGL1)baselineFibrinogen-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
body mass index ,BMIbaselineBMI=weight(kg)/height(m)\^2
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 scoreTime Frame: baselineThe 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)
LHbaselineluteinizing hormone
FSHbaselinefollicle-stimulating hormone
FBGbaselinefasting blood-glucose
PBGbaselinepostprandial blood-glucose
FINSbaselinefasting serum insulin
PINSbaselinepostprandial serum insulin
ASTbaselineaspartate aminotransferase
ALTbaselinealanine aminotransferase
UAbaselineUric acid
CRbaselineCreatinine
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.
DHEASbaselinedehydroepiandrosterone(nmol/L)
SHBGbaselinesex hormone-binding globulin (nmol/L)

Countries

China

Contacts

CONTACTManna Zhang, Dr
mannazhang@126.com86-21-66301004
STUDY_CHAIRShen Qu, Dr

Shanghai 10th People's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026