Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047574
• Other study ID #: Multidisciplinary treat PCOS
• Status: Recruiting
• Start date: September 18, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: March 2024
• Source: Shanghai 10th People's Hospital
• Contact: Manna Zhang, Dr
• Phone: 86-21-66301004
• Email: mannazhang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: July 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• This study does not involve any interventions
This study does not involve any interventions

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrinogen-like-protein 1 (FGL1)	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	body mass index ,BMI	BMI=weight(kg)/height(m)^2	baseline
Secondary	Waist/hip Ratio,WHR	WHR=Waist Circumference(cm)/Hip Circumference(cm)	baseline
Secondary	Number of menstruation in the last year	physiological parameter,the total number of menstrual periods in the last year	baseline
Secondary	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.	Time Frame: baseline
Secondary	HOMA-IR	Homeostatic model assessment insulin resistance index	baseline
Secondary	TT	total testosterone (nmol/L)	baseline
Secondary	FT	Free testosterone (nmol/L)	baseline
Secondary	LH	luteinizing hormone	baseline
Secondary	FSH	follicle-stimulating hormone	baseline
Secondary	FBG	fasting blood-glucose	baseline
Secondary	PBG	postprandial blood-glucose	baseline
Secondary	FINS	fasting serum insulin	baseline
Secondary	PINS	postprandial serum insulin	baseline
Secondary	AST	aspartate aminotransferase	baseline
Secondary	ALT	alanine aminotransferase	baseline
Secondary	UA	Uric acid	baseline
Secondary	CR	Creatinine	baseline
Secondary	LDL-c	low-density lipoprotein cholesterol	baseline
Secondary	HDL-c	high-density lipoprotein cholesterol	baseline
Secondary	TC	Total Cholesterol (mmol/L)	baseline
Secondary	TG	Triglyceride (mmol/L)	baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Chemerin	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.	baseline
Secondary	omentin-1	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.	baseline
Secondary	leptin	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.	baseline
Secondary	RBP-4	A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.	baseline
Secondary	adiponectin	A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.	baseline
Secondary	DHEAS	dehydroepiandrosterone(nmol/L)	baseline
Secondary	SHBG	sex hormone-binding globulin (nmol/L)	baseline