Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency

Not Applicable

• Conditions: Primary Ovarian Insufficiency
• Interventions: Drug: Vitamin E; Drug: Resveratrol

• Registration Number: NCT05410093
• Lead Sponsor: Affiliated Hospital of Nantong University

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.

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02-01
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-06-06
• Last Update Submitted: 2022-06-06
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Patients who taking VitE	Vitamin E	Take vitamin E at a dose of 100 mg per day for three months
Patients who taking Resveratrol	Resveratrol	Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months

Primary Outcome Measures

Name	Time	Method
Follicle-stimulating hormone (FSH)	Third day of menstruation	Compare Differences
Luteinizing hormone (LH)	Third day of menstruation	Compare Differences

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

B ultrasound; 🇨🇳 Nantong, Jiangsu, China