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

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05410093
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
29.9
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Follicle-stimulating hormone (FSH) [Third day of menstruation]

      Compare Differences

    2. Luteinizing hormone (LH) [Third day of menstruation]

      Compare Differences

    Secondary Outcome Measures

    1. Anti-Mullerian hormone (AMH) [Third day of menstruation]

      Compare Differences

    2. Estradiol hormone (E2) [Third day of menstruation]

      Compare Differences

    3. Testosterone (T) [Third day of menstruation]

      Compare Differences

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 B ultrasound Nantong Jiangsu China 226000

    Sponsors and Collaborators

    • Affiliated Hospital of Nantong University

    Investigators

    • Study Chair: wang xia, Master, Hospital affiliated of nantong university

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Affiliated Hospital of Nantong University
    ClinicalTrials.gov Identifier:
    NCT05410093
    Other Study ID Numbers:
    • LCYJ-B05
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Primary Ovarian Insufficiency
    Menopause, Premature
    Vitamin E
    Tocopherols
    Resveratrol

    Study Results

    No Results Posted as of Jun 8, 2022