Polycystic Ovary SyndromNCT06325969
PCOS Patients' Immune Alterations
An observational study of Polycystic Ovary Syndrom and Metformin, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrom, Metformin, Immune Function
- What is being tested?
- Detect the immune function of peripheral blood samples
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2023to 10 Jul 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
- Healthy volunteers accepted
- Adult
Study population: Women older than 18 years or younger than 45 years.
Who may be able to join
- Female subjects aged 18-45 years;
- Voluntarily participate in the experiment, willing to sign the informed consent.
- According to the Rotterdam consensus, polycystic ovarian syndrome (PCOS) needs to meet the presence of two of three of the following criteria: oligo-anovulation, hyperandrogenism, and polycystic ovaries (≥ 12 follicles measuring 2-9 mm in diameter and/or an ovarian volume > 10 mL in at least one ovary).
Who cannot join
- Female patients younger than 18 years old or older than 45 years old;
- Ovulation disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction (hyperthyroidism, hypothyroidism);
- Congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, adrenal tumors, and other diseases causing hyperandrogenemia;
- Severe liver and kidney dysfunction (more than 3 times the normal value)
- Type 1 diabetes, monogenic mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes;
- History of malignant tumor;
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- Severe infection, severe anemia, neutropenia, and other chronic diseases of the system;
- Patients undergoing total hysterectomy or ovarian adnexectomy;
- Mental illness, dementia, or other cognitive behavioral problems;
- Hypoglycemic drugs that may affect insulin resistance and androgen levels, including thiazolidinedione, metformin, SGLT-2i, acarbose, and glucagon-like peptide-1 receptor agonist (GLP-1RA), have been used in the past 3 months;
- Take letrozole, clomiphene, oral contraceptives, glucocorticoids, gonadotropins, gonadotropin-releasing hormone agonists, antiandrogens (spironolactone, cyproterone acetate, flutamide, etc.), and other medications for PCOS treatment within the last 3 months.
- Pregnant or lactating patients;
- Female patients with a BMI less than 20kg/m2.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, 200072
About this study
Official title: Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome
In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients.
Read the detailed description
PCOS patients and healthy women were recruited in outpatient clinics of three hospitals, and peripheral blood was retained for flow cytometry after completing relevant examinations. In this study, flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescence-labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
- Conditions
- Polycystic Ovary Syndrom, Metformin, Immune Function
- Being tested
- Detect the immune function of peripheral blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detect the immune function of peripheral blood samplesDiagnostic test
Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients.
| Study group | Role | What they receive |
|---|---|---|
| Women with PCOS | Women aged 18 to 45 who meet the 2003 Rotterdam criteria for PCOS. Receives: Diagnostic Test: Detect the immune function of peripheral blood samples | |
| Women without PCOS | Non-PCOS women aged 18 to 45. Receives: Diagnostic Test: Detect the immune function of peripheral blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
Measured: Samples to be collected once per participant within 7 days of enrollment.
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Secondary outcomes (14)
Homeostasis model assessment of insulin resistance
insulin resistance index
Measured: Within 7 days of enrollment.
body mass index
body mass index (kg/m2)
Measured: Within 7 days of enrollment.
menstrual frequency
number of menstruation in a year
Measured: Within 7 days of enrollment.
fasting glucose
fasting glucose (mmol/L)
Measured: Within 7 days of enrollment.
fasting insulin
fasting insulin (mmol/L)
Measured: Within 7 days of enrollment.
Total cholesterol
Total cholesterol (mmol/L)
Measured: Within 7 days of enrollment.
Triglycerides
Triglycerides (mmol/L)
Measured: Within 7 days of enrollment.
HDL-c
HDL-c (mmol/L)
Measured: Within 7 days of enrollment.
LDL-c
LDL-c (mmol/L)
Measured: Within 7 days of enrollment.
total testosterone
total testosterone (nmol/L)
Measured: Within 7 days of enrollment.
free testosterone
free testosterone (nmol/L)
Measured: Within 7 days of enrollment.
Sex hormone-binding globulin
Sex hormone-binding globulin (nmol/L)
Measured: Within 7 days of enrollment.
Androstenedione
Androstenedione (ng/ml)
Measured: Within 7 days of enrollment.
Dehydroepiandrosterone
Dehydroepiandrosterone (ug/dl)
Measured: Within 7 days of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start3 Nov 2023
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
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
- Manna Zhang, doctor, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325969
- Sponsor's protocol ID
- PCOS Immune
- Status last verified
- Jul 2025
- First submitted
- 8 Mar 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Status in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06325969
- Acronym / sponsor ID
- PCOS Immune
- Conditions
- Polycystic Ovary Syndrom, Metformin, Immune Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 22 Mar 2024 (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.
In this study, the investigators will include PCOS patients and healthy women who meet the trial criteria from the clinical research centers of 3 hospitals, introduce the content of this study to participants, and invite participants to participate. Flow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients, to clarify the immune function characteristics of PCOS patients, and to try to establish an evaluation method of the immune function of PCOS patients.
Detailed description
PCOS patients and healthy women were recruited in outpatient clinics of three hospitals, and peripheral blood was retained for flow cytometry after completing relevant examinations. In this study, flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescence-labeled antibody in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with PCOS | – | Diagnostic Test: Detect the immune function of peripheral blood samplesWomen aged 18 to 45 who meet the 2003 Rotterdam criteria for PCOS. |
| Women without PCOS | – | Diagnostic Test: Detect the immune function of peripheral blood samplesNon-PCOS women aged 18 to 45. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women older than 18 years or younger than 45 years.
Key inclusion criteria (3 listed)
- Female subjects aged 18-45 years;
- Voluntarily participate in the experiment, willing to sign the informed consent.
- According to the Rotterdam consensus, polycystic ovarian syndrome (PCOS) needs to meet the presence of two of three of the following criteria: oligo-anovulation, hyperandrogenism, and polycystic ovaries (≥ 12 follicles measuring 2-9 mm in diameter and/or an ovarian volume > 10 mL in at least one ovary).
Key exclusion criteria (13 listed)
- Female patients younger than 18 years old or older than 45 years old;
- Ovulation disorders caused by premature ovarian failure, pituitary amenorrhea, hypothalamic amenorrhea, and thyroid dysfunction (hyperthyroidism, hypothyroidism);
- Congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, adrenal tumors, and other diseases causing hyperandrogenemia;
- Severe liver and kidney dysfunction (more than 3 times the normal value)
- Type 1 diabetes, monogenic mutation diabetes, diabetes due to pancreatic injury or other secondary 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 |
|---|---|---|
| Detect the immune function of peripheral blood samplesFlow cytometry was used to detect the immune function of peripheral blood samples of PCOS patients. | Diagnostic test | Women with PCOS, Women without PCOS |
Primary outcome
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.
14 secondary outcomes
Homeostasis model assessment of insulin resistance
Time frame: Within 7 days of enrollment.
body mass index
Time frame: Within 7 days of enrollment.
menstrual frequency
Time frame: Within 7 days of enrollment.
fasting glucose
Time frame: Within 7 days of enrollment.
fasting insulin
Time frame: Within 7 days of enrollment.
Total cholesterol
Time frame: Within 7 days of enrollment.
Triglycerides
Time frame: Within 7 days of enrollment.
HDL-c
Time frame: Within 7 days of enrollment.
LDL-c
Time frame: Within 7 days of enrollment.
total testosterone
Time frame: Within 7 days of enrollment.
free testosterone
Time frame: Within 7 days of enrollment.
Sex hormone-binding globulin
Time frame: Within 7 days of enrollment.
Androstenedione
Time frame: Within 7 days of enrollment.
Dehydroepiandrosterone
Time frame: Within 7 days of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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.
Manna Zhang, doctor principal investigator
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 Syndrom and Metformin, 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 11 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry. (time frame: Samples to be collected once per participant within 7 days of enrollment.). The study lists 2 primary outcomes in all. 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 11 Jul 2025.