Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

NCT ID: NCT06047574

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2025-07-30

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

PCOS

1. Oligomenorrhea/amenorrhea

2. Clinical androgen excess or biochemical androgen excess

3. Polycystic ovary showed by gynecological ultrasound

This study does not involve any interventions

Intervention Type: OTHER

This study does not involve any interventions

NOPCOS

not meet Rotterdam standards

This study does not involve any interventions

Intervention Type: OTHER

This study does not involve any interventions

Interventions

This study does not involve any interventions

This study does not involve any interventions

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Director, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen Qu, Dr

Role: STUDY_CHAIR

Shanghai 10th People's Hospital

Locations

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Manna Zhang, Dr

Role: CONTACT

mannazhang@126.com

86-21-66301004

Facility Contacts

Manna Zhang, Ph.D

Role: primary

mannazhang@126.com

86-21-66301004

Other Identifiers

Multidisciplinary treat PCOS

Identifier Type: -

Identifier Source: org_study_id