Primary Ovarian Insufficiency
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGResveratrol
Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
DRUGVitamin E
Take vitamin E at a dose of 100 mg per day for three months
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Amenorrhea or oligomenorrhea at least 4 months and two (\>4 weeks interval) basal FSH≥10mIU/ml； 2. The women aged \<40 years old； 3. Informed consent, voluntary experiment.
Exclusion criteria
1. Pregnant and lactating patients; 2. Patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids\>4 cm or hysterectomy; 3. Patients with adrenal cortical hyperplasia or tumour； 4. Ovarian neoplasms patients； 5. Hydrosalpinx patients； 6. Hyperprolactinemia patients； 7. Patients who are participating in other clinical trials or have participated in other clinical trials within the past three months; 8. Patients with a suspected or real history of alcohol and drug abuse; 9. Known allergy to the investigational drug or its components; 10. Other patients were deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicle-stimulating hormone (FSH) | Third day of menstruation | Compare Differences |
| Luteinizing hormone (LH) | Third day of menstruation | Compare Differences |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estradiol hormone (E2) | Third day of menstruation | Compare Differences |
| Testosterone (T) | Third day of menstruation | Compare Differences |
| Anti-Mullerian hormone (AMH) | Third day of menstruation | Compare Differences |
Countries
China
Contacts
Primary Contactwang xia, Master
Outcome results
None listed