Androgen ProfileRES-IVFNCT01782911
Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients
A study testing Resveratrol in people with Androgen Profile and Inflammatory Markers, run by IVI Madrid at 1 site in Spain.
Trial summary
Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Androgen Profile, Inflammatory Markers, IVF Outcome
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2013to 1 Feb 2013
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged from 18 to 40 years old.
- PCOS diagnosis (according to Rotterdam criteria).
- Mild or moderate male factor, tubal factor or unknown infertility.
Who cannot join
- Follicle stimulation hormone (third of day of menstruation) > 10 milli international units/L.
- Endometriosis (III o IV).
- Congenital adrenal hyperplasia.
- Cushing syndrome.
- Hyperprolactinemia.
- Thyroid disease.
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- Androgenic hormone secretor tumors.
- Patients included in this trial did not take either oral contraceptives, steroids or other medications that could modify the ovarian function, insulin sensitivity or lipid metabolism 3 months before the onset of the trial.
- Severe male factor (sperm concentration < 5 mill/ml).
- Patients undergoing oocyte vitrification to avoid hyperstimulation syndrome will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).
- Conditions
- Androgen Profile, Inflammatory Markers, IVF Outcome
- Being tested
- Resveratrol, Placebo pills
- Keywords
- Androgen, IVF, Resveratrol, PCOS.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
The patients will take 2 g of resveratrol per day for 40 days.
Placebo pillsDietary supplement
The patients will take placebo for 40 days.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Patients will be given 2 g of resveratrol a day from the onset of menses until ovarian pick-up. Receives: Dietary Supplement: Resveratrol |
| Control | Placebo comparator | Patients will be given pills lacking medication from the onset of menses until the ovum pick-up. Receives: Dietary Supplement: Placebo pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of resveratrol on oocyte quality
Measured: 40 days
Secondary outcomes (4)
Effect of resveratrol on testosterone levels.
Measured: 40 days
Effects of resveratrol on inflammatory markers
Measured: 40 days
Effects of resveratrol on the fertilization rate.
Measured: 40 days
Effects of resveratrol on the pregnancy rate.
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study start1 Feb 2013
- Primary completion1 Feb 2013
- Study completion1 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgen ProfileStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan A Garcia-Velasco, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782911
- Sponsor's protocol ID
- MAD-IO-01-2013-01
- Acronym
- RES-IVF
- Status last verified
- Aug 2019
- First submitted
- 28 Jan 2013
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.
PubMed 32851663
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients Undergoing IVF Treatment.
- ClinicalTrials.gov ID
- NCT01782911
- Acronym / sponsor ID
- RES-IVF / MAD-IO-01-2013-01
- Conditions
- Androgen Profile, Inflammatory Markers, IVF Outcome
- Keywords
- Androgen, IVF, Resveratrol, PCOS.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Feb 2013 (actual)
- Study completion
- 1 Feb 2013 (actual)
- First posted
- 4 Feb 2013 (estimated)
- 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.
Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolPatients will be given 2 g of resveratrol a day from the onset of menses until ovarian pick-up. |
| Control | Placebo comparator | Dietary Supplement: Placebo pillsPatients will be given pills lacking medication from the onset of menses until the ovum pick-up. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged from 18 to 40 years old.
- PCOS diagnosis (according to Rotterdam criteria).
- Mild or moderate male factor, tubal factor or unknown infertility.
Key exclusion criteria (10 listed)
- Follicle stimulation hormone (third of day of menstruation) > 10 milli international units/L.
- Endometriosis (III o IV).
- Congenital adrenal hyperplasia.
- Cushing syndrome.
- Hyperprolactinemia.
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 |
|---|---|---|
| ResveratrolThe patients will take 2 g of resveratrol per day for 40 days. | Dietary supplement | Resveratrol |
| Placebo pillsThe patients will take placebo for 40 days. | Dietary supplement | Control |
Primary outcome
Effect of resveratrol on oocyte quality
Time frame: 40 days
4 secondary outcomes
Effect of resveratrol on testosterone levels.
Time frame: 40 days
Effects of resveratrol on inflammatory markers
Time frame: 40 days
Effects of resveratrol on the fertilization rate.
Time frame: 40 days
Effects of resveratrol on the pregnancy rate.
Time frame: 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Derived from this study: PubMed 32851663Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Androgen Profile and Inflammatory Markers, run by IVI Madrid at 1 site in Spain.
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: finished, as of the sponsor's last update on 20 Aug 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of resveratrol on oocyte quality (time frame: 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01782911, which also lists 1 linked publication.
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 20 Aug 2019.