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

NCT ID: NCT05410093

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2024-07-31

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.

Conditions

Primary Ovarian Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Patients who taking Resveratrol

Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DRUG

Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months

Patients who taking VitE

Take vitamin E at a dose of 100 mg per day for three months

Group Type: ACTIVE_COMPARATOR

Vitamin E

Intervention Type: DRUG

Take vitamin E at a dose of 100 mg per day for three months

Interventions

Resveratrol

Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months

Intervention Type: DRUG

Vitamin E

Take vitamin E at a dose of 100 mg per day for three months

Intervention Type: DRUG

Other Intervention Names

Res; tocopherol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

wang xia, Master

Role: STUDY_CHAIR

Hospital affiliated of nantong university

Locations

B ultrasound

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

wang xia, Master

Role: CONTACT

77109666@qq.com

15996663288

Facility Contacts

wang xia, Master

Role: primary

77109666@qq.com

15996663288

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LCYJ-B05

Identifier Type: -

Identifier Source: org_study_id