Clinical trial NCT06047574: Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome
Official title: Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Clinical characteristics
New biomarkers
Multidisciplinary
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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).

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.


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.

Primary outcomes:
measure: Fibrinogen-like-protein 1 (FGL1)
timeFrame: baseline
Secondary outcomes:
measure: body mass index ,BMI
timeFrame: baseline
measure: Waist/hip Ratio,WHR
timeFrame: baseline
measure: Number of menstruation in the last year
timeFrame: baseline
measure: Ferriman-Gallwey score
timeFrame: Time Frame: baseline
measure: HOMA-IR
timeFrame: baseline
measure: TT
timeFrame: baseline
measure: FT
timeFrame: baseline
measure: LH
timeFrame: baseline
measure: FSH
timeFrame: baseline
measure: FBG
timeFrame: baseline
measure: PBG
timeFrame: baseline
measure: FINS
timeFrame: baseline
measure: PINS
timeFrame: baseline
measure: AST
timeFrame: baseline
measure: ALT
timeFrame: baseline
measure: UA
timeFrame: baseline
measure: CR
timeFrame: baseline
measure: LDL-c
timeFrame: baseline
measure: HDL-c
timeFrame: baseline
measure: TC
timeFrame: baseline
measure: TG
timeFrame: baseline
measure: Interleukin 22#IL-22
timeFrame: baseline
measure: Interleukin 6#IL-6
timeFrame: baseline
measure: Interleukin 8# IL-8
timeFrame: baseline
measure: Tumor Necrosis Factor# TNF
timeFrame: baseline
measure: Chemerin
timeFrame: baseline
measure: omentin-1
timeFrame: baseline
measure: leptin
timeFrame: baseline
measure: RBP-4
timeFrame: baseline
measure: adiponectin
timeFrame: baseline
measure: DHEAS
timeFrame: baseline
measure: SHBG
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Shen Qu, Dr
role: STUDY_CHAIR
References: