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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-arginine intervention with 3g daily treatment for three months | Experimental | L-arginine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-arginine intervention | Drug | L-arginine intervention for 3 months, 3 g per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| menstrual frequency | number of menstruation in a year | Within 7 days of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Homeostasis model assessment of insulin resistance | insulin resistance index | Within 7 days of enrollment |
| body mass index | body mass index (kg/m2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manna Zhang, doctor | Shanghai 10th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Shanghai Tenth People's Hospital | Shanghai | 200072 | China | |||
| Shanghai Tenth People's Hospital |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Within 7 days of enrollment. |
| fasting glucose | fasting glucose (mmol/L) | Within 7 days of enrollment. |
| fasting insulin | fasting insulin (mmol/L) | Within 7 days of enrollment. |
| Total cholesterol | Total cholesterol (mmol/L) | Within 7 days of enrollment. |
| Triglycerides | Triglycerides (mmol/L) | Within 7 days of enrollment. |
| HDL-c | HDL-c (mmol/L) | Within 7 days of enrollment. |
| LDL-c | LDL-c (mmol/L) | Within 7 days of enrollment. |
| total testosterone | total testosterone (nmol/L) | Within 7 days of enrollment. |
| free testosterone | free testosterone (nmol/L) | Within 7 days of enrollment. |
| Sex hormone-binding globulin | Sex hormone-binding globulin (nmol/L) | Within 7 days of enrollment. |
| Androstenedione | Androstenedione (ng/ml) | Within 7 days of enrollment. |
| Dehydroepiandrosterone | Dehydroepiandrosterone (ug/dl) | Within 7 days of enrollment. |
| Shanghai |
| 200072 |
| China |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |