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Completed

NCT Number: NCT06728644

The Role of L-arginine in 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L-arginine intervention

Drug

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

Primary outcomes

  1. menstrual frequency

    Time frame: Within 7 days of enrollment

    number of menstruation in a year

Secondary outcomes

  1. Homeostasis model assessment of insulin resistance

    Time frame: Within 7 days of enrollment

    insulin resistance index

  2. body mass index

    Time frame: Within 7 days of enrollment.

    body mass index (kg/m2)

  3. fasting glucose

    Time frame: Within 7 days of enrollment.

    fasting glucose (mmol/L)

  4. fasting insulin

    Time frame: Within 7 days of enrollment.

    fasting insulin (mmol/L)

  5. Total cholesterol

    Time frame: Within 7 days of enrollment.

    Total cholesterol (mmol/L)

  6. Triglycerides

    Time frame: Within 7 days of enrollment.

    Triglycerides (mmol/L)

  7. HDL-c

    Time frame: Within 7 days of enrollment.

    HDL-c (mmol/L)

  8. LDL-c

    Time frame: Within 7 days of enrollment.

    LDL-c (mmol/L)

  9. total testosterone

    Time frame: Within 7 days of enrollment.

    total testosterone (nmol/L)

  10. free testosterone

    Time frame: Within 7 days of enrollment.

    free testosterone (nmol/L)

  11. Sex hormone-binding globulin

    Time frame: Within 7 days of enrollment.

    Sex hormone-binding globulin (nmol/L)

  12. Androstenedione

    Time frame: Within 7 days of enrollment.

    Androstenedione (ng/ml)

  13. Dehydroepiandrosterone

    Time frame: Within 7 days of enrollment.

    Dehydroepiandrosterone (ug/dl)

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

The Safety and Efficacy of L-arginine in Patients With Polycystic Ovary Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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