Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Multidisciplinary Combined Precise 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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Manna Zhang, Dr; Phone Number: 86-21-66301004; Email: mannazhang@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200070
      • Recruiting
      • Department of Endocrinology, Shanghai Tenth People's Hospital
      • Contact: Manna Zhang, Ph.D; Phone Number: 86-21-66301004; Email: mannazhang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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;

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.

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
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 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
HOMA-IR	Homeostatic model assessment insulin resistance index	baseline
TT	total testosterone (nmol/L)	baseline
FT	Free testosterone (nmol/L)	baseline
LH	luteinizing hormone	baseline
FSH	follicle-stimulating hormone	baseline
PBG	postprandial blood-glucose	baseline
FINS	fasting 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
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
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
FBG	fasting blood-glucose	baseline
PINS	postprandial serum insulin	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
DHEAS	dehydroepiandrosterone（nmol/L）	baseline
SHBG	sex hormone-binding globulin (nmol/L)	baseline

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

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