Polycystic Ovary SyndromeNCT06047574
Multidisciplinary Diagnosis and Treatment of 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 (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between… 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
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2023to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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;
Who cannot join
- Female patients younger than 18 years old or older than 45 years old;
- Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction;
- Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism;
- Abnormal liver or renal function((≥ 3 times of the upper limit of normal range)
- Type 1 diabetes, single gene mutation diabetes, or pancreatic damage Diabetes or other secondary diabetes caused by diabetes;
- History of malignant tumors;
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- Severe infection, severe anemia, neutropenia and other systemic chronic diseases;
- Undergo total hysterectomy or ovarian adnexectomy;
- Mental illness, dementia or other cognitive behavioral problems;
- Use hypoglycemic drugs that may affect insulin resistance and androgen levels in the last 3 months, including thiazolidinediones, metformin, SGLT-2, and acarbose and GLP-1RA and other drugs;
- Use letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, anti-androgens (spironolactone, Cyproterone acetate, flutamide, etc.) and other drugs for the treatment of PCOS.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200070
Manna Zhang, Ph.D, 86-21-66301004, mannazhang@126.com
About this study
Official title: Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome
The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to 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, Multidisciplinary
- 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.
Fibrinogen-like-protein 1 (FGL1)
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 (32)
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: Time Frame: 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
LH
luteinizing hormone
Measured: baseline
FSH
follicle-stimulating hormone
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
DHEAS
dehydroepiandrosterone（nmol/L）
Measured: baseline
SHBG
sex hormone-binding globulin (nmol/L)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Sep 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 3,000 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, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047574
- Sponsor's protocol ID
- Multidisciplinary treat PCOS
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Combined Precise Diagnosis and Treatment of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06047574
- Acronym / sponsor ID
- Multidisciplinary treat PCOS
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, Clinical characteristics, New biomarkers, Multidisciplinary
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 21 Sep 2023 (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 (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to 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 (1 listed)
- Female aged 18- 45;
Key exclusion criteria (11 listed)
- Female patients younger than 18 years old or older than 45 years old;
- Ovulatory disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction;
- Congenital adrenal hyperplasia, reservoir Hin syndrome, hyperprolactinemia, adrenal tumors and other diseases that cause hyperandrogenism;
- Abnormal liver or renal function((≥ 3 times of the upper limit of normal range)
- Type 1 diabetes, single gene mutation diabetes, or pancreatic damage Diabetes or other secondary diabetes caused by diabetes;
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
Fibrinogen-like-protein 1 (FGL1)
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.
32 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: Time Frame: baseline
HOMA-IR
Time frame: baseline
TT
Time frame: baseline
FT
Time frame: baseline
LH
Time frame: baseline
FSH
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
DHEAS
Time frame: baseline
SHBG
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
Shen Qu, Dr study chair
Shanghai 10th 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manna Zhang, Dr (86-21-66301004, mannazhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrinogen-like-protein 1 (FGL1) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.