PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesNCT05802212
Effect of Metformin on Patients With Polycystic Ovary Syndrome
A study testing Metformin intervention for 12 weeks in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of the study is to understand the effect of Metformin on patients with PCOS. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- What is being tested?
- Metformin intervention for 12 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 May 2023
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
- Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
- Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention.
- Volunteers with polycystic ovary syndrome without insulin resistance.
Who cannot join
- Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- Individuals who are during pregnant, lactation or menopause.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
- Use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months.
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- Individuals with severe liver diseases or kidney disease that are ineligible to participate in the study.
- A medical history of severe cardiovascular and cerebrovascular diseases.
- Individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption.
- Individuals who drink more than 15g of alcohol per day or have a smoking habit.
- Individuals who need drug treatment for any mental illness such as epilepsy and depression.
- Cancer patients.
- Individuals who suffer from infectious diseases such as hepatitis B, active tuberculosis, AIDS, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
The purpose of the study is to understand the effect of Metformin on patients with PCOS.
Read the detailed description
This study aims to evaluate the effects of Metformin on reproductive endocrine and reproductive outcomes in women with PCOS, and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
- Being tested
- Metformin intervention for 12 weeks
- 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.
Metformin intervention for 12 weeksDrug
Also called PCOS patients were treated with metformin for 12 weeks
PCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed.
| Study group | Role | What they receive |
|---|---|---|
| Metformin intervention for 12 weeks | Experimental | Metformin intervention for 12 weeks Receives: Drug: Metformin intervention for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luteinizing hormone in serum
Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
Measured: before and after 2, 12 weeks of intervention
4-Androstenedione in serum
Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
Measured: before and after 2, 12 weeks of intervention
Secondary outcomes (17)
Testosterone in serum
Changes of testosterone(nmol/L) in serum after the intervention.
Measured: before and after 2, 12 weeks of intervention
Estradiol in serum
Changes of estradiol(pmol/L) in serum after the intervention.
Measured: before and after 2, 12 weeks of intervention
Prolactin in serum
Changes of prolactin(ng/mL) in serum after the intervention.
Measured: before and after 2, 12 weeks of intervention
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Measured: after 12 weeks of intervention
Follicle number
The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.
Measured: before intervention
Ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Measured: after 12 weeks of intervention
Ovarian volume
The size of each ovary will be determined using transvaginal ultrasonography for each participant in early follicular phase.
Measured: before intervention
The alterations of plasma lipid metabolites
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Measured: after 12 weeks of intervention
The alterations of plasma lipid metabolites
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Measured: after 2 weeks of intervention
The alterations of plasma lipid metabolites
Determination the alterations of lipid metabolites before and after metformin intervention by metabolomics.
Measured: before intervention
Fasting insulin
Changes in plasma insulin concentration after the intervention.
Measured: before and after 2, 12 weeks of intervention
Blood sugar level
Changes in plasma glucose concentration after the intervention.
Measured: before and after 2, 12 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Measured: after 12 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Measured: after 2 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
Determination the alterations of secondary metabolites of gut fungi and bacteria before and after metformin intervention by metabolomics
Measured: before intervention
The species and genus abundance changes of fungi and bacteria gut microbiota composition
Determination the species and genus abundance changes of gut microbiota among before and after intervention by ITS genomic
Measured: before and after 2, 12 weeks of intervention
Follicular stimulating hormone in serum
Changes of follicular stimulating hormone(mIU/mL) in serum after the intervention.
Measured: before and after 2, 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Jun 2020
- Primary completion1 Jun 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Volunteers with polycystic ovary syndrome without insulin resistance and intervened with metformin for 12 weeks
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiaojie, Professor, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802212
- Sponsor's protocol ID
- M2021385
- Other IDs
- 82288102
- Status last verified
- Jan 2023
- First submitted
- 6 Feb 2023
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin Intervention on Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05802212
- Acronym / sponsor ID
- M2021385
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 6 Apr 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 purpose of the study is to understand the effect of Metformin on patients with PCOS.
Detailed description
This study aims to evaluate the effects of Metformin on reproductive endocrine and reproductive outcomes in women with PCOS, and to explore its underlying mechanisms to provide the intervention strategies for PCOS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Volunteers with polycystic ovary syndrome without insulin resistance and intervened with metformin for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Metformin intervention for 12 weeks | Experimental | Drug: Metformin intervention for 12 weeksMetformin intervention for 12 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals who are 20 to 40 years old, planning to become pregnant or infertile women.
- Individuals who are diagnosed as PCOS according to the revised 2003 Rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) Oligo- and/or anovulation; 2) Clinical and/or biochemical signs of hyperandrogenism; 3) Polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome).
- Individuals who can insist on continuous monitoring in the outpatient clinic. Individuals who are not participating in other research projects currently or 3 months before the intervention.
- Volunteers with polycystic ovary syndrome without insulin resistance.
Key exclusion criteria (13 listed)
- Individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities.
- Individuals who are during pregnant, lactation or menopause.
- Individuals who currently receiving weight-loss drugs or surgery or within the past 2 months.
- Individuals who take niacin, nicotinamide, or other vitamin B3-related supplementation currently or within the past 2 months.
- Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.
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 |
|---|---|---|
| Metformin intervention for 12 weeksAlso: PCOS patients were treated with metformin for 12 weeksPCOS patients were treated with metformin orally for 12 weeks, and various indicators related to fertility were observed. | Drug | Metformin intervention for 12 weeks |
Primary outcome
Luteinizing hormone in serum
Time frame: before and after 2, 12 weeks of intervention
Changes of luteinizing hormone(mIU/mL) in serum after the intervention.
4-Androstenedione in serum
Time frame: before and after 2, 12 weeks of intervention
Changes of 4-Androstenedione(pmol/L) in serum after the intervention.
17 secondary outcomes
Testosterone in serum
Time frame: before and after 2, 12 weeks of intervention
Estradiol in serum
Time frame: before and after 2, 12 weeks of intervention
Prolactin in serum
Time frame: before and after 2, 12 weeks of intervention
Follicle number
Time frame: after 12 weeks of intervention
Follicle number
Time frame: before intervention
Ovarian volume
Time frame: after 12 weeks of intervention
Ovarian volume
Time frame: before intervention
The alterations of plasma lipid metabolites
Time frame: after 12 weeks of intervention
The alterations of plasma lipid metabolites
Time frame: after 2 weeks of intervention
The alterations of plasma lipid metabolites
Time frame: before intervention
Fasting insulin
Time frame: before and after 2, 12 weeks of intervention
Blood sugar level
Time frame: before and after 2, 12 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
Time frame: after 12 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
Time frame: after 2 weeks of intervention
The alterations of secondary metabolites of gut fungi and bacteria
Time frame: before intervention
The species and genus abundance changes of fungi and bacteria gut microbiota composition
Time frame: before and after 2, 12 weeks of intervention
Follicular stimulating hormone in serum
Time frame: before and after 2, 12 weeks of intervention
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 25 Nov 2025.
- 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.
Qiaojie, Professor study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin intervention for 12 weeks in people with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Peking University Third 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 4 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 25 Nov 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?
Luteinizing hormone in serum (time frame: before and after 2, 12 weeks of intervention). 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 25 Nov 2025.