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

Last updated: June 6, 2022
Sponsor: Affiliated Hospital of Nantong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Perimenopause

Treatment

N/A

Clinical Study ID

NCT05410093
LCYJ-B05
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Amenorrhea or oligomenorrhea at least 4 months and two (>4 weeks interval) basalFSH≥10mIU/ml；
  2. The women aged <40 years old；
  3. Informed consent, voluntary experiment.

Exclusion

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 otherclinical 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 theinvestigator.

Study Design

Total Participants: 150
Study Start date:
February 01, 2022
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • B ultrasound

    Nantong, Jiangsu 226000
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.