Clinical trial NCT04386499: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel, single blind, grouped randomised, interventional clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: follicles
timeFrame: 6 months
measure: oocytes
timeFrame: 6 months
measure: MII oocytes
timeFrame: 6 months
measure: fertilization
timeFrame: 6 months
measure: embryos
timeFrame: 6 months
measure: blastocysts
timeFrame: 6 months
measure: gonadotropins days
timeFrame: 6 months
measure: gonadotropins IU
timeFrame: 6 months
Secondary outcomes:
measure: embryos number
timeFrame: 18 months
measure: implantation
timeFrame: 18 months
measure: pregnancy
timeFrame: 18 months
measure: live birth
timeFrame: 18 months
measure: miscarriage
timeFrame: 18 months
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: University of Perugia, Piazza Menghini 1, S. Andrea delle Fratte.
state: Umbria
Study officials:
affiliation: University Of Perugia
name: Sandro Gerli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.