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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Ovarian Insufficiency
• Intervention / Treatment: Drug: Resveratrol; Drug: Vitamin E

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wang xia, Master; Phone Number: 15996663288; Email: 77109666@qq.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • B ultrasound
      • Contact: wang xia, Master; Phone Number: 15996663288; Email: 77109666@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who taking Resveratrol; Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months	Drug: Resveratrol; Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months; Other Names: Res
Active Comparator: Patients who taking VitE; Take vitamin E at a dose of 100 mg per day for three months	Drug: Vitamin E; Take vitamin E at a dose of 100 mg per day for three months; Other Names: tocopherol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follicle-stimulating hormone (FSH)	Compare Differences	Third day of menstruation
Luteinizing hormone (LH)	Compare Differences	Third day of menstruation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-Mullerian hormone (AMH)	Compare Differences	Third day of menstruation
Estradiol hormone (E2)	Compare Differences	Third day of menstruation
Testosterone (T)	Compare Differences	Third day of menstruation

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Chair: wang xia, Master, Hospital affiliated of nantong university

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: May 16, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Primary Ovarian Insufficiency; Menopause, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E; Tocopherols; Resveratrol
• Other Study ID Numbers: LCYJ-B05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No