The Role of L-arginine in Polycystic Ovary Syndrome

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome; L-arginine; Gut Microbiome
• Interventions: Drug: L-arginine intervention

• Registration Number: NCT06728644
• Lead Sponsor: Shanghai 10th People's Hospital

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2024-12-20
• Primary Completion: 2025-08-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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 taken drugs for PCOS treatment in the last three months;
• Have a long history of taking hormone therapy;
• Currently or recently participating in another clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
L-arginine intervention with 3g daily treatment for three months	L-arginine intervention	L-arginine therapy

Primary Outcome Measures

Name	Time	Method
menstrual frequency	Within 7 days of enrollment	number of menstruation in a year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China