Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200070, China
Location status: Recruiting
Recruiting
NCT Number: NCT06047574
Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
This study does not involve any interventions
OtherThis study does not involve any interventions
Primary outcomes
-
Fibrinogen-like-protein 1 (FGL1)
Time frame: 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 outcomes
-
body mass index ,BMI
Time frame: baseline
BMI=weight(kg)/height(m)^2
-
Waist/hip Ratio,WHR
Time frame: baseline
WHR=Waist Circumference(cm)/Hip Circumference(cm)
-
Number of menstruation in the last year
Time frame: baseline
physiological parameter,the total number of menstrual periods in the last year
-
Ferriman-Gallwey score
Time frame: 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
Time frame: baseline
Homeostatic model assessment insulin resistance index
-
TT
Time frame: baseline
total testosterone (nmol/L)
-
FT
Time frame: baseline
Free testosterone (nmol/L)
-
LH
Time frame: baseline
luteinizing hormone
-
FSH
Time frame: baseline
follicle-stimulating hormone
-
FBG
Time frame: baseline
fasting blood-glucose
-
PBG
Time frame: baseline
postprandial blood-glucose
-
FINS
Time frame: baseline
fasting serum insulin
-
PINS
Time frame: baseline
postprandial serum insulin
-
AST
Time frame: baseline
aspartate aminotransferase
-
ALT
Time frame: baseline
alanine aminotransferase
-
UA
Time frame: baseline
Uric acid
-
CR
Time frame: baseline
Creatinine
-
LDL-c
Time frame: baseline
low-density lipoprotein cholesterol
-
HDL-c
Time frame: baseline
high-density lipoprotein cholesterol
-
TC
Time frame: baseline
Total Cholesterol (mmol/L)
-
TG
Time frame: baseline
Triglyceride (mmol/L)
-
Interleukin 22#IL-22
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
-
omentin-1
Time frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
-
leptin
Time frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
-
RBP-4
Time frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
-
adiponectin
Time frame: baseline
A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.
-
DHEAS
Time frame: baseline
dehydroepiandrosterone（nmol/L）
-
SHBG
Time frame: baseline
sex hormone-binding globulin (nmol/L)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Shanghai 10th People's Hospital
Other
Registry information
Official study title
Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome
Important dates
- Study start
- 2023
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Sep 21, 2023
- Registry last updated
- Mar 9, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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