An interventional study of L-arginine intervention in Polycystic Ovary Syndrome, L-arginine and Gut Microbiome, sponsored by Shanghai 10th People's Hospital. Completed at 2 sites in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
L-arginine therapy
Drug: L-arginine intervention
L-arginine intervention for 3 months, 3 g per day.
menstrual frequency
number of menstruation in a year
Time frame: Within 7 days of enrollment
Homeostasis model assessment of insulin resistance
insulin resistance index
Time frame: Within 7 days of enrollment
body mass index
body mass index (kg/m2)
Time frame: Within 7 days of enrollment.
fasting glucose
fasting glucose (mmol/L)
Time frame: Within 7 days of enrollment.
fasting insulin
fasting insulin (mmol/L)
Time frame: Within 7 days of enrollment.
Total cholesterol
Total cholesterol (mmol/L)
Time frame: Within 7 days of enrollment.
Triglycerides
Triglycerides (mmol/L)
Time frame: Within 7 days of enrollment.
HDL-c
HDL-c (mmol/L)
Time frame: Within 7 days of enrollment.
LDL-c
LDL-c (mmol/L)
Time frame: Within 7 days of enrollment.
total testosterone
total testosterone (nmol/L)
Time frame: Within 7 days of enrollment.
free testosterone
free testosterone (nmol/L)
Time frame: Within 7 days of enrollment.
Sex hormone-binding globulin
Sex hormone-binding globulin (nmol/L)
Time frame: Within 7 days of enrollment.
Androstenedione
Androstenedione (ng/ml)
Time frame: Within 7 days of enrollment.
Dehydroepiandrosterone
Dehydroepiandrosterone (ug/dl)
Time frame: Within 7 days of enrollment.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Shanghai 10th People's Hospital