InfertilityPhase 3RES-OHSSNCT03446625
Resveratrol as a Preventive Treatment of OHSS
A Phase 3 study testing Resveratrol in people with Infertility, run by IVI Madrid at 1 site in Spain.
Trial summary
Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- 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
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2018to 1 Jun 2019
- Phase
- Phase 3
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Number of follicles greater than 12 mm after ovarian stimulation
- Number of retrieved oocytes greater than 21
Who cannot join
- >35 years-old
- PCOS
- Endometriosis
- Systemic pathology
- Positive serologies for HBV, HBC and HIV
- Abnormal karyotype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome
Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors
Read the detailed description
Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving hemoconcentration and symptomathology of this condition
- Conditions
- Infertility
- Being tested
- Resveratrol, Placebo
- Keywords
- resveratrol, OHSS, PCOS
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Also called Resverasor Plus
Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
PlaceboDrug
Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Resveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering. Receives: Drug: Resveratrol; Drug: Placebo |
| Control | Placebo comparator | Placebo treatment will be administered for 9 days, starting on the day of ovulation triggering. Receives: Drug: Resveratrol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum VEGF levels
Serum determination of VEGF levels
Measured: 1 day
Secondary outcomes (3)
Hemoconcentration
Volume of red blood cells measured in percentage
Measured: 1 day
Serum estradiol levels
Serum determination of estradiol levels asessed in picograms per mililiter
Measured: 1 day
Ascitis
Volume of liquid in Douglas pouch asessed in mililiters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start13 Mar 2018
- Primary completion1 Oct 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 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
- NCT03446625
- Sponsor's protocol ID
- 1401-MAD-004-IO
- Acronym
- RES-OHSS
- Status last verified
- Aug 2018
- First submitted
- 12 Jan 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ortega I, Villanueva JA, Wong DH, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Resveratrol reduces steroidogenesis in rat ovarian theca-interstitial cells: the role of inhibition of Akt/PKB signaling pathway. Endocrinology. 2012 Aug;153(8):4019-29. doi: 10.1210/en.2012-1385. Epub 2012 Jun 19.
PubMed 22719052Ortega I, Wong DH, Villanueva JA, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Effects of resveratrol on growth and function of rat ovarian granulosa cells. Fertil Steril. 2012 Dec;98(6):1563-73. doi: 10.1016/j.fertnstert.2012.08.004. Epub 2012 Sep 6.
PubMed 22959450Basini G, Tringali C, Baioni L, Bussolati S, Spatafora C, Grasselli F. Biological effects on granulosa cells of hydroxylated and methylated resveratrol analogues. Mol Nutr Food Res. 2010 Jul;54 Suppl 2:S236-43. doi: 10.1002/mnfr.200900320.
PubMed 20140899
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
- Resveratrol as a Preventive Treatment of Ovarian Hyperstimulation Syndrome
- ClinicalTrials.gov ID
- NCT03446625
- Acronym / sponsor ID
- RES-OHSS / 1401-MAD-004-IO
- Conditions
- Infertility
- Keywords
- resveratrol, OHSS, PCOS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 27 Feb 2018 (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.
Evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors
Detailed description
Randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing VGEF expression and estradiol production, imporving hemoconcentration and symptomathology of this condition
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Drug: Resveratrol, Drug: PlaceboResveratrol will be administered orally at the dose of 2 g/day for 9 days, starting on the day of ovulation triggering. |
| Control | Placebo comparator | Drug: Resveratrol, Drug: PlaceboPlacebo treatment will be administered for 9 days, starting on the day of ovulation triggering. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Number of follicles greater than 12 mm after ovarian stimulation
- Number of retrieved oocytes greater than 21
Key exclusion criteria (6 listed)
- >35 years-old
- PCOS
- Endometriosis
- Systemic pathology
- Positive serologies for HBV, HBC and HIV
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: Resverasor PlusResveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day. | Drug | Control, Resveratrol |
| PlaceboPlacebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day. | Drug | Control, Resveratrol |
Primary outcome
Serum VEGF levels
Time frame: 1 day
Serum determination of VEGF levels
3 secondary outcomes
Hemoconcentration
Time frame: 1 day
Serum estradiol levels
Time frame: 1 day
Ascitis
Time frame: 1 day
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.
- Background: PubMed 22719052Ortega I, Villanueva JA, Wong DH, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Resveratrol reduces steroidogenesis in rat ovarian theca-interstitial cells: the role of inhibition of Akt/PKB signaling pathway. Endocrinology. 2012 Aug;153(8):4019-29. doi: 10.1210/en.2012-1385. Epub 2012 Jun 19.
- Background: PubMed 22959450Ortega I, Wong DH, Villanueva JA, Cress AB, Sokalska A, Stanley SD, Duleba AJ. Effects of resveratrol on growth and function of rat ovarian granulosa cells. Fertil Steril. 2012 Dec;98(6):1563-73. doi: 10.1016/j.fertnstert.2012.08.004. Epub 2012 Sep 6.
- Background: PubMed 20140899Basini G, Tringali C, Baioni L, Bussolati S, Spatafora C, Grasselli F. Biological effects on granulosa cells of hydroxylated and methylated resveratrol analogues. Mol Nutr Food Res. 2010 Jul;54 Suppl 2:S236-43. doi: 10.1002/mnfr.200900320.
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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 Phase 3 study testing Resveratrol in people with Infertility, 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 2 inclusion and 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum VEGF levels (time frame: 1 day). 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 NCT03446625, which also lists 3 linked publications.
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.