Clinical trial NCT05063383: Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome
Official title: Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
clinical characteristics
new biomarkers
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 600
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 in this study, used statistical software such as SPSS for data analysis, and used experimental techniques such as ELISA to detect serum samples, aiming to explore the relationship between the body anthropometry, glucose and lipid metabolism, gonadal hormones and body fat distribution in patients with polycystic ovary syndrome and to discovery new biomarkers and promote the realization of more accurate personalized medicine.


Eligibility criteria: Inclusion Criteria:

* Female aged 18- 45;
* Meet Rotterdam criteria;

Exclusion Criteria:

* Women who are pregnant or have a pregnancy plan within six months;
* Congenital adrenocortical hyperplasia;
* Hyperprolactinemia;
* Hyperthyroidism or hypothyroidism;
* Abnormal liver function (≥ 3 times of the upper limit of normal range);
* Abnormal renal function (GFR\<60ml/min/1.73m2);
* Adrenal or ovarian tumors secreting androgens;
* Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.

Primary outcomes:
measure: diagnostic markers of PCOS patients
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: baseline
measure: HOMA-IR
timeFrame: baseline
measure: TT
timeFrame: baseline
measure: FT
timeFrame: baseline
measure: SHBG
timeFrame: baseline
measure: LH
timeFrame: baseline
measure: FSH
timeFrame: baseline
measure: DHEAS
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: resistin
timeFrame: baseline
measure: Visfatin
timeFrame: baseline
measure: Apelin
timeFrame: baseline
measure: Vaspin.
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People' Hospital
state: Shanghai
Study officials:
affiliation: Shang hai Tenth People's Hospital
name: Shen Qu, Dr
role: STUDY_CHAIR
References: