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

Primary Ovarian Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410093
• Other study ID #: LCYJ-B05
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2022
• Source: Affiliated Hospital of Nantong University
• Contact: wang xia, Master
• Phone: 15996663288
• Email: 77109666[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Menopause, Premature
• Primary Ovarian Insufficiency

Intervention

Drug:
• Resveratrol
Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
• Vitamin E
Take vitamin E at a dose of 100 mg per day for three months

Locations

Country	Name	City	State
China	B ultrasound	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Follicle-stimulating hormone (FSH)	Compare Differences	Third day of menstruation
Primary	Luteinizing hormone (LH)	Compare Differences	Third day of menstruation
Secondary	Anti-Mullerian hormone (AMH)	Compare Differences	Third day of menstruation
Secondary	Estradiol hormone (E2)	Compare Differences	Third day of menstruation
Secondary	Testosterone (T)	Compare Differences	Third day of menstruation