The Role of L-arginine in Polycystic Ovary Syndrome

NCT06728644 | Completed DMC

• 1 other identifier: L-arginine and PCOS
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Polycystic Ovary Syndrome; L-arginine; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• menstrual frequency

  number of menstruation in a year

  Within 7 days of enrollment

Secondary Outcomes (13)

• Homeostasis model assessment of insulin resistance

  Within 7 days of enrollment

• body mass index

  Within 7 days of enrollment.

• fasting glucose

  Within 7 days of enrollment.

• fasting insulin

  Within 7 days of enrollment.

• Total cholesterol

  Within 7 days of enrollment.

Study Arms (1)

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

EXPERIMENTAL

L-arginine therapy

Drug: L-arginine intervention

Interventions

L-arginine intervention DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (2)

Department of Endocrinology, Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Manna Zhang, doctor

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: July 14, 2024
• Primary Completion: July 4, 2025
• Study Completion: July 4, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)