Primary Ovarian InsufficiencyNCT05410093
Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
A study testing Resveratrol and Vitamin E in people with Primary Ovarian Insufficiency, run by Affiliated Hospital of Nantong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Primary Ovarian Insufficiency
- What is being tested?
- Resveratrol and Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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；
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
B ultrasound
Nantong, Jiangsu, 226000
wang xia, Master, 15996663288, 77109666@qq.com
About this study
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.
Read the 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
- Being tested
- Resveratrol, Vitamin E
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called Res
Take Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months
Vitamin EDrug
Also called tocopherol
Take vitamin E at a dose of 100 mg per day for three months
| Study group | Role | What they receive |
|---|---|---|
| Patients who taking Resveratrol | Experimental | Take RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months Receives: Drug: Resveratrol |
| Patients who taking VitE | Active comparator | Take vitamin E at a dose of 100 mg per day for three months Receives: Drug: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle-stimulating hormone (FSH)
Compare Differences
Measured: Third day of menstruation
Luteinizing hormone (LH)
Compare Differences
Measured: Third day of menstruation
Secondary outcomes (3)
Anti-Mullerian hormone (AMH)
Compare Differences
Measured: Third day of menstruation
Estradiol hormone (E2)
Compare Differences
Measured: Third day of menstruation
Testosterone (T)
Compare Differences
Measured: Third day of menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Feb 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wang xia, Master, Study chair, Hospital affiliated of nantong university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410093
- Sponsor's protocol ID
- LCYJ-B05
- Status last verified
- Feb 2022
- First submitted
- 16 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Analysis of Resveratrol in the Treatment of Primary Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT05410093
- Acronym / sponsor ID
- LCYJ-B05
- Conditions
- Primary Ovarian Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who taking Resveratrol | Experimental | Drug: ResveratrolTake RES (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months |
| Patients who taking VitE | Active comparator | Drug: Vitamin ETake vitamin E at a dose of 100 mg per day for three months |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolAlso: ResTake Resveratrol (250mg, NuMedica, FDA approved) at a dose of 250mg per day for three months | Drug | Patients who taking Resveratrol |
| Vitamin EAlso: tocopherolTake vitamin E at a dose of 100 mg per day for three months | Drug | Patients who taking VitE |
Primary outcome
Follicle-stimulating hormone (FSH)
Time frame: Third day of menstruation
Compare Differences
Luteinizing hormone (LH)
Time frame: Third day of menstruation
Compare Differences
3 secondary outcomes
Anti-Mullerian hormone (AMH)
Time frame: Third day of menstruation
Estradiol hormone (E2)
Time frame: Third day of menstruation
Testosterone (T)
Time frame: Third day of menstruation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wang xia, Master study chair
Hospital affiliated of nantong university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol and Vitamin E in people with Primary Ovarian Insufficiency, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wang xia, Master (15996663288, 77109666@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follicle-stimulating hormone (FSH) (time frame: Third day of menstruation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.