Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome

NCT05063383 — Unknown, 600 participants, Shanghai 10th People's Hospital

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RegistryNCT05063383
StatusUnknown
Study typeObservational
Enrollment600 (Estimated)
SponsorShanghai 10th People's Hospital (Other)
ConditionsPolycystic Ovary Syndrome
InterventionsThis study does not involve any interventions (Other)
Datesstart 2019-01-01, primary completion 2025-06-30 (estimated), completion 2025-12-30 (estimated), first posted 2021-10-01, last updated 2024-11-19
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Polycystic Ovary Syndrome All trials of This study does not involve any interventions

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
PCOSOther: This study does not involve any interventions1. Oligomenorrhea/amenorrhea 2. Clinical androgen excess or biochemical androgen excess 3. Polycystic ovary showed by gynecological ultrasound
NOPCOSOther: This study does not involve any interventionsnot meet Rotterdam standards
  • This study does not involve any interventions (Other): This study does not involve any interventions

+Outcome measures

Primary outcomes

  • diagnostic markers of PCOS patients [baseline]: Fibrinogen-like-protein 1 (FGL1), is a novel hepatokine that plays an important role in hepatic steatosis, insulin resistance and obesity. There is no maximum or minimum value for this parameter and the higher scores mean a worse outcome.

Secondary outcomes

  • body mass index ,BMI [baseline]: BMI=weight(kg)/height(m)\^2
  • Waist/hip Ratio,WHR [baseline]: WHR=Waist Circumference(cm)/Hip Circumference(cm)
  • Number of menstruation in the last year [baseline]: physiological parameter,the total number of menstrual periods in the last year
  • Ferriman-Gallwey score [baseline]: The minimum value of Ferriman-Gallwey score is 0 and the maximum value is 44. An Ferriman-Gallwey score greater than or equal to 6 is considered to be a clinical manifestation of androgen excess.
  • HOMA-IR [baseline]: Homeostatic model assessment insulin resistance index
  • TT [baseline]: total testosterone (nmol/L)
  • FT [baseline]: Free testosterone (nmol/L)
  • SHBG [baseline]: SHBG (nmol/L)
  • LH [baseline]: luteinizing hormone
  • FSH [baseline]: follicle-stimulating hormone
  • DHEAS [baseline]: dehydroepiandrosterone
  • FBG [baseline]: fasting blood-glucose;
  • PBG [baseline]: postprandial blood-glucose
  • FINS [baseline]: fasting serum insulin
  • PINS, [baseline]: postprandial serum insulin
  • AST [baseline]: aspartate aminotransferase
  • ALT [baseline]: alanine aminotransferase
  • UA [baseline]: Uric acid
  • CR [baseline]: Creatinine
  • LDL-c [baseline]: low-density lipoprotein cholesterol
  • HDL-c [baseline]: high-density lipoprotein cholesterol
  • TC [baseline]: Total Cholesterol (mmol/L)
  • TG [baseline]: Triglyceride (mmol/L)
  • Interleukin 22,IL-22 [baseline]: The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
  • Interleukin 6,IL-6 [baseline]: IL-6. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
  • Interleukin 8, IL-8 [baseline]: The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
  • Tumor Necrosis Factor, TNF [baseline]: The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
  • Chemerin [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • omentin-1 [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • leptin [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • RBP-4 [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • adiponectin [baseline]: A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • resistin [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • Visfatin [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • Apelin [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
  • Vaspin. [baseline]: A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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.

+Locations (1)

FacilityCityCountryStatus
Shanghai Tenth People' HospitalShanghai, Shanghai MunicipalityChinaRecruiting

+Publications

  • Results publication: Su K, Zhao Y, Chai H, Cai M, Dilimulati D, Zhang Y, Shao X, Qu S, Liu C, Zhang M. Remission of polycystic ovary syndrome based on the recovery of ovarian morphology identified by three-dimensional ultrasonography: a retrospective study. Front Endocrinol (Lausanne). 2026 Jul 30;17:1877873. doi: 10.3389/fendo.2026.1877873. eCollection 2026. PMID 42597837

+Investigators

  • Shen Qu, Dr, Study chair, Shang hai Tenth People's Hospital