Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Luteinizing hormone (LH)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Amenorrhea or oligomenorrhea at least 4 months and two (>4 weeks interval) basal FSH≥10mIU/ml；
- •The women aged <40 years old；
- •Informed consent, voluntary experiment.
排除标准
- •Pregnant and lactating patients;
- •Patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids>4 cm or hysterectomy;
- •Patients with adrenal cortical hyperplasia or tumour；
- •Ovarian neoplasms patients；
- •Hydrosalpinx patients；
- •Hyperprolactinemia patients；
- •Patients who are participating in other clinical trials or have participated in other clinical trials within the past three months;
- •Patients with a suspected or real history of alcohol and drug abuse;
- •Known allergy to the investigational drug or its components;
- •Other patients were deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
Patients who taking Resveratrol
Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
干预措施: Resveratrol (Drug)
Patients who taking VitE
Take vitamin E at a dose of 100 mg per day for three months
干预措施: Vitamin E (Drug)
结局指标
主要结局
Luteinizing hormone (LH)
时间窗: Third day of menstruation
Compare Differences
Follicle-stimulating hormone (FSH)
时间窗: Third day of menstruation
Compare Differences
次要结局
- Anti-Mullerian hormone (AMH)(Third day of menstruation)
- Testosterone (T)(Third day of menstruation)
- Estradiol hormone (E2)(Third day of menstruation)