Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

NCT06047574 | Recruiting

• 1 other identifier: Multidisciplinary treat PCOS
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Clinical characteristics; New biomarkers; Multidisciplinary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (32)

• body mass index ,BMI

  baseline

• Waist/hip Ratio,WHR

  baseline

• Number of menstruation in the last year

  baseline

• Ferriman-Gallwey score

  Time Frame: baseline

• HOMA-IR

  baseline

Study Arms (2)

PCOS

1. Oligomenorrhea/amenorrhea 2. Clinical androgen excess or biochemical androgen excess 3. Polycystic ovary showed by gynecological ultrasound

Other: This study does not involve any interventions

NOPCOS

not meet Rotterdam standards

Other: This study does not involve any interventions

Interventions

This study does not involve any interventions OTHER

This study does not involve any interventions

NOPCOS; PCOS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• Female aged 18- 45;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200070, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Shen Qu, Dr

  Shanghai 10th People's Hospital

  STUDY CHAIR

Central Study Contacts

Manna Zhang, Dr

CONTACT

86-21-66301004; mannazhang@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)