The Role of L-arginine in Polycystic Ovary Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Gut Microbiome; L-arginine
• Intervention / Treatment: Drug: L-arginine intervention

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital
  • Shanghai, China, 200072
    • Department of Endocrinology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 18-45 years
• Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)

Exclusion Criteria:

• 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;
• Patients with mental illness or intellectual disability;
• Have a long history of taking hormone therapy;
• Currently or recently participating in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-arginine intervention with 3g daily treatment for three months; L-arginine therapy	Drug: L-arginine intervention; L-arginine intervention for 3 months, 3 g per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
menstrual frequency	number of menstruation in a year	Within 7 days of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	body mass index (kg/m2)	Within 7 days of enrollment.
fasting glucose	fasting glucose (mmol/L)	Within 7 days of enrollment.
fasting insulin	fasting insulin (mmol/L)	Within 7 days of enrollment.
Total cholesterol	Total cholesterol (mmol/L)	Within 7 days of enrollment.
Triglycerides	Triglycerides (mmol/L)	Within 7 days of enrollment.
HDL-c	HDL-c (mmol/L)	Within 7 days of enrollment.
LDL-c	LDL-c (mmol/L)	Within 7 days of enrollment.
total testosterone	total testosterone (nmol/L)	Within 7 days of enrollment.
free testosterone	free testosterone (nmol/L)	Within 7 days of enrollment.
Sex hormone-binding globulin	Sex hormone-binding globulin (nmol/L)	Within 7 days of enrollment.
Androstenedione	Androstenedione (ng/ml)	Within 7 days of enrollment.
Dehydroepiandrosterone	Dehydroepiandrosterone (ug/dl)	Within 7 days of enrollment.
Homeostasis model assessment of insulin resistance	insulin resistance index	Within 7 days of enrollment

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Principal Investigator: Manna Zhang, doctor, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2024
• Primary Completion (Actual): July 4, 2025
• Study Completion (Actual): July 4, 2025

Study Registration Dates

• First Submitted: December 8, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: L-arginine and PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No