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

NCT05063383 | Recruiting

• 1 other identifier: Clinical Characteristics PCOS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; clinical characteristics; new biomarkers

Outcome Measures

Primary Outcomes (1)

• diagnostic markers of PCOS patients

  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.

  baseline

Secondary Outcomes (36)

• body mass index ,BMI

  baseline

• Waist/hip Ratio,WHR

  baseline

• Number of menstruation in the last year

  baseline

• Ferriman-Gallwey score

  baseline

• HOMA-IR

  baseline

Study Arms (2)

PCOS

1. Oligomenorrhea/amenorrhea 2. Clinical androgen excess or biochemical androgen excess 3. Polycystic ovary showed by gynecological ultrasound

Other: This study does not involve any interventions

NOPCOS

not meet Rotterdam standards

Other: This study does not involve any interventions

Interventions

This study does not involve any interventions OTHER

This study does not involve any interventions

NOPCOS; PCOS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Shen Qu, Dr

  Shang hai Tenth People's Hospital

  STUDY CHAIR

Central Study Contacts

Manna Zhang, Dr

CONTACT

（86）66301004; mannazhang@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 1, 2021
• Study Start: January 1, 2019
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)