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Recruiting NCT06047574

Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Observational Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This study does not involve any interventions.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome

Overview

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.

Interventions

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

Primary outcome measures

  • Fibrinogen-like-protein 1 (FGL1) [Time frame: baseline]
Secondary outcome measures (12)
  • body mass index ,BMI [Time frame: baseline]
  • Waist/hip Ratio,WHR [Time frame: baseline]
  • Number of menstruation in the last year [Time frame: baseline]
  • Ferriman-Gallwey score [Time frame: Time Frame: baseline]
  • HOMA-IR [Time frame: baseline]
  • TT [Time frame: baseline]
  • FT [Time frame: baseline]
  • LH [Time frame: baseline]
  • FSH [Time frame: baseline]
  • FBG [Time frame: baseline]
  • PBG [Time frame: baseline]
  • FINS [Time frame: baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Department of Endocrinology, Shanghai Tenth People's Hospital — Shanghai

Identifiers

NCT: NCT06047574 · Multidisciplinary treat PCOS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗