Polycystic Ovary SyndromeNCT06728644
The Role of L-arginine in Polycystic Ovary Syndrome
A study testing L-arginine intervention in people with Polycystic Ovary Syndrome and L-arginine, run by Shanghai 10th People's Hospital at 2 sites in China.
Trial summary
PCOS patients meeting the trial criteria were enrolled from the Shanghai 10th People's Hospital. The contents of this study were introduced to them, and they were invited to participate in the study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, L-arginine, Gut Microbiome
- What is being tested?
- L-arginine intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jul 2024to 4 Jul 2025
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged 18-45 years
- Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
Who cannot join
- Pregnant women;
- Hyperthyroidism or hypothyroidism
- Severe liver and kidney function injury
- Cancer patients;
- Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
- Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
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- Patients with mental illness or intellectual disability;
- Have a long history of taking hormone therapy;
- Currently or recently participating in another clinical trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, 200072
Shanghai Tenth People's Hospital
Shanghai, 200072
About this study
Official title: The Safety and Efficacy of L-arginine in Patients With Polycystic Ovary Syndrome
PCOS patients meeting the trial criteria were enrolled from the Shanghai 10th People's Hospital. The contents of this study were introduced to them, and they were invited to participate in the study. We further evaluated the efficacy and safety of arginine in treating PCOS by implementing the L-arginine clinical intervention protocol, and conducting post-intervention follow-up, efficacy evaluation, laboratory tests, and fecal sample 16S rRNA sequencing.
Read the detailed description
In this study, we will enroll PCOS patients who meet the trial criteria from the Shanghai 10th People's Hospital, introduce the content of this study to them, and invite them to participate in the study. Perform laboratory tests for PCOS and collect baseline stool and blood samples. The clinical intervention program of L-arginine was implemented, and post-intervention follow-up, efficacy evaluation and laboratory examination were carried out. Stool and blood samples were collected after the intervention, and 16S rRNA sequencing was performed on stool samples before and after the intervention. To analyze whether PCOS-related clinical and laboratory indicators improved after L-arginine treatment of PCOS, and to analyze the changes in patients' microbiome before and after L-arginine treatment, to clarify the effectiveness and safety of L-arginine treatment of PCOS.
- Conditions
- Polycystic Ovary Syndrome, L-arginine, Gut Microbiome
- Being tested
- L-arginine intervention
- 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.
L-arginine interventionDrug
L-arginine intervention for 3 months, 3 g per day.
| Study group | Role | What they receive |
|---|---|---|
| L-arginine intervention with 3g daily treatment for three months | Experimental | L-arginine therapy Receives: Drug: L-arginine intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
menstrual frequency
number of menstruation in a year
Measured: Within 7 days of enrollment
Secondary outcomes (13)
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.
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 posted11 Dec 2024
- Study start14 Jul 2024
- Primary completion4 Jul 2025
- Study completion4 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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT06728644
- Sponsor's protocol ID
- L-arginine and PCOS
- Status last verified
- Jul 2025
- First submitted
- 8 Dec 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
- The Safety and Efficacy of L-arginine in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06728644
- Acronym / sponsor ID
- L-arginine and PCOS
- Conditions
- Polycystic Ovary Syndrome, L-arginine, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 11 Dec 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.
PCOS patients meeting the trial criteria were enrolled from the Shanghai 10th People's Hospital. The contents of this study were introduced to them, and they were invited to participate in the study. We further evaluated the efficacy and safety of arginine in treating PCOS by implementing the L-arginine clinical intervention protocol, and conducting post-intervention follow-up, efficacy evaluation, laboratory tests, and fecal sample 16S rRNA sequencing.
Detailed description
In this study, we will enroll PCOS patients who meet the trial criteria from the Shanghai 10th People's Hospital, introduce the content of this study to them, and invite them to participate in the study. Perform laboratory tests for PCOS and collect baseline stool and blood samples. The clinical intervention program of L-arginine was implemented, and post-intervention follow-up, efficacy evaluation and laboratory examination were carried out. Stool and blood samples were collected after the intervention, and 16S rRNA sequencing was performed on stool samples before and after the intervention. To analyze whether PCOS-related clinical and laboratory indicators improved after L-arginine treatment of PCOS, and to analyze the changes in patients' microbiome before and after L-arginine treatment, to clarify the effectiveness and safety of L-arginine treatment of PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-arginine intervention with 3g daily treatment for three months | Experimental | Drug: L-arginine interventionL-arginine therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged 18-45 years
- Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)
Key exclusion criteria (9 listed)
- Pregnant women;
- Hyperthyroidism or hypothyroidism
- Severe liver and kidney function injury
- Cancer patients;
- Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
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 |
|---|---|---|
| L-arginine interventionL-arginine intervention for 3 months, 3 g per day. | Drug | L-arginine intervention with 3g daily treatment for three months |
Primary outcome
menstrual frequency
Time frame: Within 7 days of enrollment
number of menstruation in a year
13 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.
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
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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.
Manna Zhang, doctor principal investigator
Shanghai 10th People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-arginine intervention in people with Polycystic Ovary Syndrome and L-arginine, run by Shanghai 10th People's Hospital at 2 sites 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 9 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 2 sites 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?
menstrual frequency (time frame: Within 7 days of enrollment). 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.