Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
Primary Purpose
Primary Ovarian Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Resveratrol
Vitamin E
Sponsored by
About this trial
This is an interventional treatment trial for Primary Ovarian Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Amenorrhea or oligomenorrhea at least 4 months and two (>4 weeks interval) basal FSH≥10mIU/ml;
- The women aged <40 years old;
- Informed consent, voluntary experiment.
Exclusion Criteria:
- Pregnant and lactating patients;
- Patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids>4 cm or hysterectomy;
- Patients with adrenal cortical hyperplasia or tumour;
- Ovarian neoplasms patients;
- Hydrosalpinx patients;
- Hyperprolactinemia patients;
- Patients who are participating in other clinical trials or have participated in other clinical trials within the past three months;
- Patients with a suspected or real history of alcohol and drug abuse;
- Known allergy to the investigational drug or its components;
- Other patients were deemed unsuitable for participation in this trial by the investigator.
Sites / Locations
- B ultrasoundRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients who taking Resveratrol
Patients who taking VitE
Arm Description
Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
Take vitamin E at a dose of 100 mg per day for three months
Outcomes
Primary Outcome Measures
Follicle-stimulating hormone (FSH)
Compare Differences
Luteinizing hormone (LH)
Compare Differences
Secondary Outcome Measures
Anti-Mullerian hormone (AMH)
Compare Differences
Estradiol hormone (E2)
Compare Differences
Testosterone (T)
Compare Differences
Full Information
NCT ID
NCT05410093
First Posted
May 16, 2022
Last Updated
June 6, 2022
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05410093
Brief Title
Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
Official Title
Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Ovarian Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients who taking Resveratrol
Arm Type
Experimental
Arm Description
Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
Arm Title
Patients who taking VitE
Arm Type
Active Comparator
Arm Description
Take vitamin E at a dose of 100 mg per day for three months
Intervention Type
Drug
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
Res
Intervention Description
Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
tocopherol
Intervention Description
Take vitamin E at a dose of 100 mg per day for three months
Primary Outcome Measure Information:
Title
Follicle-stimulating hormone (FSH)
Description
Compare Differences
Time Frame
Third day of menstruation
Title
Luteinizing hormone (LH)
Description
Compare Differences
Time Frame
Third day of menstruation
Secondary Outcome Measure Information:
Title
Anti-Mullerian hormone (AMH)
Description
Compare Differences
Time Frame
Third day of menstruation
Title
Estradiol hormone (E2)
Description
Compare Differences
Time Frame
Third day of menstruation
Title
Testosterone (T)
Description
Compare Differences
Time Frame
Third day of menstruation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Amenorrhea or oligomenorrhea at least 4 months and two (>4 weeks interval) basal FSH≥10mIU/ml;
The women aged <40 years old;
Informed consent, voluntary experiment.
Exclusion Criteria:
Pregnant and lactating patients;
Patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids>4 cm or hysterectomy;
Patients with adrenal cortical hyperplasia or tumour;
Ovarian neoplasms patients;
Hydrosalpinx patients;
Hyperprolactinemia patients;
Patients who are participating in other clinical trials or have participated in other clinical trials within the past three months;
Patients with a suspected or real history of alcohol and drug abuse;
Known allergy to the investigational drug or its components;
Other patients were deemed unsuitable for participation in this trial by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wang xia, Master
Phone
15996663288
Email
77109666@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wang xia, Master
Organizational Affiliation
Hospital affiliated of nantong university
Official's Role
Study Chair
Facility Information:
Facility Name
B ultrasound
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wang xia, Master
Phone
15996663288
Email
77109666@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
We'll reach out to this number within 24 hrs