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Resveratrol is a natural plant antitoxin widely found in grapes, mulberries, and other plants. Resveratrol mediates a variety of pharmacological effects, including antioxidant, immunomodulatory, anti-inflammatory, and anti-apoptotic, and plays a protective and therapeutic role in the development of several ROS-related diseases, including POI/POF.
The preliminary experiments of the investigators' group examined the gene expression in ovarian granulosa cells of POI patients and normal controls using high-throughput sequencing technology. The investigators found that the expression of NOX complex NCF1, NCF2, NCF4 and CYBB subunit genes were upregulated in ovarian granulosa cells of POI patients compared with normal controls, suggesting that the development of POI may be related to the NOX complex subunit gene and The development of POI may be related to the abnormal expression of genes and proteins of NOX complex subunits. Based on the results of previous experiments and available literature reports, investigators compared ovarian function, embryonic laboratory indices, pregnancy outcome and cellular level NOX/ROS/oxidative stress changes of POI patients in the RES-treated and non-RES-treated groups by collecting blood and ovarian granulosa cell samples to analyze the effects, mechanisms of action and specific RES application in antioxidant therapy for POI NOX subunit targets to provide a reliable scientific basis for the clinical treatment of POI by RES.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who taking Resveratrol | Experimental | Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months |
|
| Patients who taking VitE | Active Comparator | Take vitamin E at a dose of 100 mg per day for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Follicle-stimulating hormone (FSH) | Compare Differences | Third day of menstruation |
| Luteinizing hormone (LH) | Compare Differences | Third day of menstruation |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Mullerian hormone (AMH) | Compare Differences | Third day of menstruation |
| Estradiol hormone (E2) | Compare Differences | Third day of menstruation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wang xia, Master | Contact | 15996663288 | 77109666@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| wang xia, Master | Hospital affiliated of nantong university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| B ultrasound | Recruiting | Nantong | Jiangsu | 226000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2022 | Jun 6, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2022 | Jun 6, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D014810 | Vitamin E |
| D024505 | Tocopherols |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Vitamin E | Drug | Take vitamin E at a dose of 100 mg per day for three months |
|
|
| Testosterone (T) | Compare Differences | Third day of menstruation |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |