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Infertility, FemaleNCT04386499

Biological Effects of Treatment With Resveratrol in ART Patients

A study testing Resveratrol and Folic acid in people with Infertility, Female, run by University Of Perugia at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark GENANTE) on gamete quality in order to improve the reproductive process during ART. Read more about this study

Who is it for?
Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female
What is being tested?
Resveratrol and Folic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
10 Jan 2019to 5 May 2020
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 42 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women with a diagnosis of infertility
  • BMI between 18 and 30 kg/m2,
  • regular uterine cavity
  • normal thyroid function
  • normal blood parameters

Who cannot join

  • primary or secondary ovarian failure
  • patients who adhered to Bologna Criteria (at least two of the following: advanced maternal age >40, less than 3 oocytes recovered in previous attempts, abnormal ovarian reserve test)
  • presence of ovaries inaccessible to the oocyte pick-up,
  • persistent ovarian cysts > 20 mm,
  • presence of sactosalpinx
  • heterologous fertilization, significant systemic disease or other situations unsuitable for ovarian stimulation

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.

    Perugia, Umbria, 06156

Other trials in Italy

About this study

Official title: Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART)

To evaluate the effects of a new nutraceutical formulation containing resveratrol (trademark GENANTE) on gamete quality in order to improve the reproductive process during ART.

Read the detailed description

The purpose of the study is to evaluate the effect of a new nutraceutical formulation containing resveratrol (trademark Genante) on gamete quality in order to improve the reproductive protocols during Assisted reproductive technology (ART) protocols.

The study is a randomized, single blind, parallel, comparative, experimental study during the pre-treatment before in vitro fertilization-embryo transfer (IVF-ET). A total number of 100 patients will be enrolled: 50 patients with a pretreatment control group (control group) and 50 patients with experimental pretreatment study group (resveratrol group). Patients will be assigned to groups during the recruitment phase in a randomized manner. In the control group, the treatment will consist of taking 400 microg once a day of folic acid commonly suggested as part of clinical practice, while in the Resveratrol Group, patients will receive one tablet twice a day (two tablets/day) of Genante. It is specified that the pretreatment with Genante includes folic acid in accordance with the clinical practice, 400 total microg per day. Both treatments will last for 3 months before the IVF procedure.

Being tested
Resveratrol, Folic acid
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResveratrolDietary supplement

    Also called Genante (S&R Farmaceutici S.p.A, Italy)

    mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6

  • Folic acidDietary supplement

    400 mcg of folic acid

Study groups in NCT04386499
Study groupRoleWhat they receive
ResveratrolExperimentalA nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D
Receives: Dietary Supplement: Resveratrol
Folic acidActive comparatorFolic Acid 400 ug
Receives: Dietary Supplement: Folic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. follicles

    Number of follicles >16 mm

    Measured: 6 months

  2. oocytes

    number of recovered oocytes

    Measured: 6 months

  3. MII oocytes

    percentage of metaphase II oocytes

    Measured: 6 months

  4. fertilization

    fertilization rates

    Measured: 6 months

  5. embryos

    number of embryos

    Measured: 6 months

  6. blastocysts

    number of blastocysts

    Measured: 6 months

  7. gonadotropins days

    duration of ovarian stimulation (days)

    Measured: 6 months

  8. gonadotropins IU

    dosage of gonadotropins (total IU during ovarian stimulation)

    Measured: 6 months

Secondary outcomes (5)

  1. embryos number

    number of embryos per transfer

    Measured: 18 months

  2. implantation

    Implantation rate

    Measured: 18 months

  3. pregnancy

    clinical pregnancy rate

    Measured: 18 months

  4. live birth

    live birth rate

    Measured: 18 months

  5. miscarriage

    miscarriage rate

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start10 Jan 2019
  3. Primary completion11 Mar 2020
  4. Study completion5 May 2020

Resources

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
Model description
parallel, single blind, grouped randomised, interventional clinical study
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386499
Sponsor's protocol ID
SR001
Status last verified
May 2020
First submitted
5 May 2020
Last updated
13 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gerli S, Della Morte C, Ceccobelli M, Mariani M, Favilli A, Leonardi L, Lanti A, Iannitti RG, Fioretti B. Biological and clinical effects of a resveratrol-based multivitamin supplement on intracytoplasmic sperm injection cycles: a single-center, randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):7640-7648. doi: 10.1080/14767058.2021.1958313. Epub 2021 Aug 1.

    PubMed 34338114

Questions about this trial

What is this clinical trial studying?

A study testing Resveratrol and Folic acid in people with Infertility, Female, run by University Of Perugia at 1 site in Italy.

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 5 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 13 May 2020. 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 Italy. 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?

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?

follicles (time frame: 6 months). The study lists 8 primary outcomes in all. 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 NCT04386499, 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 13 May 2020.

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