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Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

T

Tongji University

Status

Enrolling

Conditions

Polycystic Ovary Syndrome

Treatments

Other: This study does not involve any interventions

Study type

Observational

Funder types

Other

Identifiers

NCT06047574
Multidisciplinary treat PCOS

Details and patient eligibility

About

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.

Enrollment

3,000 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

PCOS
Description:
1. Oligomenorrhea/amenorrhea 2. Clinical androgen excess or biochemical androgen excess 3. Polycystic ovary showed by gynecological ultrasound
Treatment:
Other: This study does not involve any interventions
NOPCOS
Description:
not meet Rotterdam standards
Treatment:
Other: This study does not involve any interventions

Trial contacts and locations

1

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Central trial contact

Manna Zhang, Dr

Data sourced from clinicaltrials.gov

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