The Role of L-arginine in Polycystic Ovary Syndrome

NCT ID: NCT06728644

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-14
• Study Completion Date: 2025-07-04

Brief 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. 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.

Conditions

Polycystic Ovary Syndrome; L-arginine; Gut Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L-arginine intervention with 3g daily treatment for three months

L-arginine therapy

Group Type: EXPERIMENTAL

L-arginine intervention

Intervention Type: DRUG

L-arginine intervention for 3 months, 3 g per day.

Interventions

L-arginine intervention

L-arginine intervention for 3 months, 3 g per day.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manna Zhang, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, , China

Shanghai Tenth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

L-arginine and PCOS

Identifier Type: -

Identifier Source: org_study_id