Polycystic Ovary SyndromeNCT05063383
Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- This study does not involve any interventions
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- Female aged 18- 45;
- Meet Rotterdam criteria;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People' Hospital
Shanghai, Shanghai Municipality, 200072
About this study
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
- Being tested
- This study does not involve any interventions
- Keywords
- Polycystic Ovary Syndrome, clinical characteristics, new biomarkers
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not involve any interventionsOther
This study does not involve any interventions
| Study group | Role | What they receive |
|---|---|---|
| PCOS | 1. Oligomenorrhea/amenorrhea
2. Clinical androgen excess or biochemical androgen excess
3. Polycystic ovary showed by gynecological ultrasound Receives: Other: This study does not involve any interventions | |
| NOPCOS | not meet Rotterdam standards Receives: Other: This study does not involve any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (36)
body mass index ,BMI
BMI=weight(kg)/height(m)^2
Measured: baseline
Waist/hip Ratio,WHR
WHR=Waist Circumference(cm)/Hip Circumference(cm)
Measured: baseline
Number of menstruation in the last year
physiological parameter,the total number of menstrual periods in the last year
Measured: baseline
Ferriman-Gallwey score
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.
Measured: baseline
HOMA-IR
Homeostatic model assessment insulin resistance index
Measured: baseline
TT
total testosterone (nmol/L)
Measured: baseline
FT
Free testosterone (nmol/L)
Measured: baseline
SHBG
SHBG (nmol/L)
Measured: baseline
LH
luteinizing hormone
Measured: baseline
FSH
follicle-stimulating hormone
Measured: baseline
DHEAS
dehydroepiandrosterone
Measured: baseline
FBG
fasting blood-glucose;
Measured: baseline
PBG
postprandial blood-glucose
Measured: baseline
FINS
fasting serum insulin
Measured: baseline
PINS,
postprandial serum insulin
Measured: baseline
AST
aspartate aminotransferase
Measured: baseline
ALT
alanine aminotransferase
Measured: baseline
UA
Uric acid
Measured: baseline
CR
Creatinine
Measured: baseline
LDL-c
low-density lipoprotein cholesterol
Measured: baseline
HDL-c
high-density lipoprotein cholesterol
Measured: baseline
TC
Total Cholesterol (mmol/L)
Measured: baseline
TG
Triglyceride (mmol/L)
Measured: baseline
Interleukin 22，IL-22
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.
Measured: baseline
Interleukin 6，IL-6
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.
Measured: baseline
Interleukin 8， IL-8
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.
Measured: baseline
Tumor Necrosis Factor， TNF
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.
Measured: baseline
Chemerin
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
omentin-1
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
leptin
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
RBP-4
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
adiponectin
A adipocytokine. The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
resistin
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
Visfatin
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
Apelin
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
Vaspin.
A adipocytokine.The factor is expressed in adipose tissue and is related to specific adipose tissue function.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start1 Jan 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Shen Qu, Dr, Study chair, Shang hai Tenth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063383
- Sponsor's protocol ID
- Clinical Characteristics PCOS
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2021
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42597837
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Characteristics and Study of Diagnostic Markers in Patients with Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05063383
- Acronym / sponsor ID
- Clinical Characteristics PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, clinical characteristics, new biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS | – | Other: This study does not involve any interventions1. Oligomenorrhea/amenorrhea 2. Clinical androgen excess or biochemical androgen excess 3. Polycystic ovary showed by gynecological ultrasound |
| NOPCOS | – | Other: This study does not involve any interventionsnot meet Rotterdam standards |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (2 listed)
- Female aged 18- 45;
- Meet Rotterdam criteria;
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study does not involve any interventionsThis study does not involve any interventions | Other | NOPCOS, PCOS |
Primary outcome
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.
36 secondary outcomes
body mass index ,BMI
Time frame: baseline
Waist/hip Ratio,WHR
Time frame: baseline
Number of menstruation in the last year
Time frame: baseline
Ferriman-Gallwey score
Time frame: baseline
HOMA-IR
Time frame: baseline
TT
Time frame: baseline
FT
Time frame: baseline
SHBG
Time frame: baseline
LH
Time frame: baseline
FSH
Time frame: baseline
DHEAS
Time frame: baseline
FBG
Time frame: baseline
PBG
Time frame: baseline
FINS
Time frame: baseline
PINS,
Time frame: baseline
AST
Time frame: baseline
ALT
Time frame: baseline
UA
Time frame: baseline
CR
Time frame: baseline
LDL-c
Time frame: baseline
HDL-c
Time frame: baseline
TC
Time frame: baseline
TG
Time frame: baseline
Interleukin 22，IL-22
Time frame: baseline
Interleukin 6，IL-6
Time frame: baseline
Interleukin 8， IL-8
Time frame: baseline
Tumor Necrosis Factor， TNF
Time frame: baseline
Chemerin
Time frame: baseline
omentin-1
Time frame: baseline
leptin
Time frame: baseline
RBP-4
Time frame: baseline
adiponectin
Time frame: baseline
resistin
Time frame: baseline
Visfatin
Time frame: baseline
Apelin
Time frame: baseline
Vaspin.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Derived from this study: PubMed 42597837Su 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shen Qu, Dr study chair
Shang hai Tenth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manna Zhang, Dr (（86）66301004, mannazhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic markers of PCOS patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.