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CompletedNCT04386499Updated May 13, 2020

Biological Effects of Treatment With Resveratrol in ART Patients

An interventional study of Resveratrol and Folic acid in Infertility, Female, sponsored by University Of Perugia. Completed at 1 site in Italy. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-13.

Sponsored by University Of Perugia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Infertility, Female

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03

In context

Infertility, Female

553 studies on the registry are indexed under Infertility, Female; 136 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 377 interventional studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

University Of Perugia is the lead sponsor of 54 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Resveratrol

    A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D

    Dietary Supplement: Resveratrol

  • Active comparator
    Folic acid

    Folic Acid 400 ug

    Dietary Supplement: Folic acid

Interventions

  • Dietary supplementResveratrol

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

    Also known as: Genante (S&R Farmaceutici S.p.A, Italy)

  • Dietary supplementFolic acid

    400 mcg of folic acid

06

What researchers measure

Primary outcomes

  1. follicles

    Number of follicles \>16 mm

    Time frame: 6 months

  2. oocytes

    number of recovered oocytes

    Time frame: 6 months

  3. MII oocytes

    percentage of metaphase II oocytes

    Time frame: 6 months

  4. fertilization

    fertilization rates

    Time frame: 6 months

  5. embryos

    number of embryos

    Time frame: 6 months

  6. blastocysts

    number of blastocysts

    Time frame: 6 months

  7. gonadotropins days

    duration of ovarian stimulation (days)

    Time frame: 6 months

  8. gonadotropins IU

    dosage of gonadotropins (total IU during ovarian stimulation)

    Time frame: 6 months

Secondary outcomes

  1. embryos number

    number of embryos per transfer

    Time frame: 18 months

  2. implantation

    Implantation rate

    Time frame: 18 months

  3. pregnancy

    clinical pregnancy rate

    Time frame: 18 months

  4. live birth

    live birth rate

    Time frame: 18 months

  5. miscarriage

    miscarriage rate

    Time frame: 18 months

07

Study locations

1 site
  • University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
    Perugia, Umbria 06156, Italy
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04386499
Lead sponsor
University Of Perugia
Responsible party
Sandro Gerli (Associate Professor of Obstetrics and Gynecology, University Of Perugia) — Principal investigator
First posted
May 13, 2020
Start date
Jan 10, 2019
Primary completion
Mar 11, 2020
Completion
May 5, 2020
Last update
May 13, 2020

Study contacts

Sandro Gerli, MD
principal investigator · University Of Perugia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Resveratrol

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