Biological Effects of Treatment With Resveratrol in ART Patients
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Resveratrol
Folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility Criteria
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:
- 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
Sites / Locations
- University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resveratrol
Folic acid
Arm Description
A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D
Folic Acid 400 ug
Outcomes
Primary Outcome Measures
follicles
Number of follicles >16 mm
oocytes
number of recovered oocytes
MII oocytes
percentage of metaphase II oocytes
fertilization
fertilization rates
embryos
number of embryos
blastocysts
number of blastocysts
gonadotropins days
duration of ovarian stimulation (days)
gonadotropins IU
dosage of gonadotropins (total IU during ovarian stimulation)
Secondary Outcome Measures
embryos number
number of embryos per transfer
implantation
Implantation rate
pregnancy
clinical pregnancy rate
live birth
live birth rate
miscarriage
miscarriage rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04386499
Brief Title
Biological Effects of Treatment With Resveratrol in ART Patients
Official Title
Effects of Treatment With Resveratrol on Oocyte and Embryo Quality in Patients Undergoing Assisted Reproductive Techniques( ART)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Of Perugia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel, single blind, grouped randomised, interventional clinical study
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resveratrol
Arm Type
Experimental
Arm Description
A nutraceutical formulation (trade mark Genante) composed of resveratrol, REVIFAST, folic acid, Vitamin D
Arm Title
Folic acid
Arm Type
Active Comparator
Arm Description
Folic Acid 400 ug
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
Genante (S&R Farmaceutici S.p.A, Italy)
Intervention Description
mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6
Intervention Type
Dietary Supplement
Intervention Name(s)
Folic acid
Intervention Description
400 mcg of folic acid
Primary Outcome Measure Information:
Title
follicles
Description
Number of follicles >16 mm
Time Frame
6 months
Title
oocytes
Description
number of recovered oocytes
Time Frame
6 months
Title
MII oocytes
Description
percentage of metaphase II oocytes
Time Frame
6 months
Title
fertilization
Description
fertilization rates
Time Frame
6 months
Title
embryos
Description
number of embryos
Time Frame
6 months
Title
blastocysts
Description
number of blastocysts
Time Frame
6 months
Title
gonadotropins days
Description
duration of ovarian stimulation (days)
Time Frame
6 months
Title
gonadotropins IU
Description
dosage of gonadotropins (total IU during ovarian stimulation)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
embryos number
Description
number of embryos per transfer
Time Frame
18 months
Title
implantation
Description
Implantation rate
Time Frame
18 months
Title
pregnancy
Description
clinical pregnancy rate
Time Frame
18 months
Title
live birth
Description
live birth rate
Time Frame
18 months
Title
miscarriage
Description
miscarriage rate
Time Frame
18 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro Gerli, MD
Organizational Affiliation
University Of Perugia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34338114
Citation
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.
Results Reference
derived
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Biological Effects of Treatment With Resveratrol in ART Patients
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