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

November 15, 2024 updated by: Zhang Manna, Shanghai 10th People's Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • Shanghai Tenth People' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
This study does not involve any interventions
NOPCOS
not meet Rotterdam standards
Other: This study does not involve any interventions
This study does not involve any interventions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
diagnostic markers of PCOS patients
Time Frame: 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.
baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body mass index ,BMI
Time Frame: baseline
BMI=weight(kg)/height(m)^2
baseline
Waist/hip Ratio,WHR
Time Frame: baseline
WHR=Waist Circumference(cm)/Hip Circumference(cm)
baseline
Number of menstruation in the last year
Time Frame: baseline
physiological parameter,the total number of menstrual periods in the last year
baseline
Ferriman-Gallwey score
Time Frame: 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.
baseline
HOMA-IR
Time Frame: baseline
Homeostatic model assessment insulin resistance index
baseline
TT
Time Frame: baseline
total testosterone (nmol/L)
baseline
FT
Time Frame: baseline
Free testosterone (nmol/L)
baseline
SHBG
Time Frame: baseline
SHBG (nmol/L)
baseline
LH
Time Frame: baseline
luteinizing hormone
baseline
FSH
Time Frame: baseline
follicle-stimulating hormone
baseline
DHEAS
Time Frame: baseline
dehydroepiandrosterone
baseline
FBG
Time Frame: baseline
fasting blood-glucose;
baseline
PBG
Time Frame: baseline
postprandial blood-glucose
baseline
FINS
Time Frame: baseline
fasting serum insulin
baseline
PINS,
Time Frame: baseline
postprandial serum insulin
baseline
AST
Time Frame: baseline
aspartate aminotransferase
baseline
ALT
Time Frame: baseline
alanine aminotransferase
baseline
UA
Time Frame: baseline
Uric acid
baseline
CR
Time Frame: baseline
Creatinine
baseline
LDL-c
Time Frame: baseline
low-density lipoprotein cholesterol
baseline
HDL-c
Time Frame: baseline
high-density lipoprotein cholesterol
baseline
TC
Time Frame: baseline
Total Cholesterol (mmol/L)
baseline
TG
Time Frame: baseline
Triglyceride (mmol/L)
baseline
Interleukin 22，IL-22
Time Frame: 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.
baseline
Interleukin 6，IL-6
Time Frame: 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.
baseline
Interleukin 8， IL-8
Time Frame: 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.
baseline
Tumor Necrosis Factor， TNF
Time Frame: 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.
baseline
Chemerin
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
omentin-1
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
leptin
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
RBP-4
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
adiponectin
Time Frame: baseline
A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
resistin
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
Visfatin
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
Apelin
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline
Vaspin.
Time Frame: baseline
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 10th People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shen Qu, Dr, Shang hai Tenth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Clinical Characteristics PCOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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