NCT04386499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1.2 years

First QC Date

May 5, 2020

Last Update Submit

May 8, 2020

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (8)

  • follicles

    Number of follicles \>16 mm

    6 months

  • oocytes

    number of recovered oocytes

    6 months

  • MII oocytes

    percentage of metaphase II oocytes

    6 months

  • fertilization

    fertilization rates

    6 months

  • embryos

    number of embryos

    6 months

  • blastocysts

    number of blastocysts

    6 months

  • gonadotropins days

    duration of ovarian stimulation (days)

    6 months

  • gonadotropins IU

    dosage of gonadotropins (total IU during ovarian stimulation)

    6 months

Secondary Outcomes (5)

  • embryos number

    18 months

  • implantation

    18 months

  • pregnancy

    18 months

  • live birth

    18 months

  • miscarriage

    18 months

Study Arms (2)

Resveratrol

EXPERIMENTAL

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

Dietary Supplement: Resveratrol

Folic acid

ACTIVE COMPARATOR

Folic Acid 400 ug

Dietary Supplement: Folic acid

Interventions

ResveratrolDIETARY_SUPPLEMENT

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)
Resveratrol
Folic acidDIETARY_SUPPLEMENT

400 mcg of folic acid

Folic acid

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Perugia, Umbria, 06156, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34338114DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

ResveratrolFolic Acid

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenolsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sandro Gerli, MD

    University Of Perugia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel, single blind, grouped randomised, interventional clinical study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 13, 2020

Study Start

January 10, 2019

Primary Completion

March 11, 2020

Study Completion

May 5, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)