The Role of L-arginine in Polycystic Ovary Syndrome

Tongji University

Status

Not yet enrolling

Conditions

L-arginine

Gut Microbiome

Polycystic Ovary Syndrome

Treatments

Drug: L-arginine intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06728644

L-arginine and PCOS

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.