Based on available evidence and given the potential beneficial effects of resveratrol in folliculogenesis and in oocyte development, the investigators designed a randomized, controlled, double-blind, single-center trial, whose objective will be the comparison of biological and clinical outcomes of resveratrol supplement in women undergoing IVF/ICSI cycles for unexplained infertility.
To the knowledge of the investigators, no study has been published on the potential effect of resveratrol on IVF/ICSI outcomes considering couples with this infertility diagnosis, which may be the natural target of this integrative treatment because the process of folliculogenesis and oocyte maturation cannot be routinely investigated. An alteration of these biological mechanisms could be the unrecognized cause of part of the unexplained infertility and treatment with resveratrol could result in significant clinical improvement for the patients enrolled in the study.
In more details, the main objective of this randomized, placebo-controlled, double-blind, single-center trial will be the evaluation of the possible effect of resveratrol in determining a better follicle development in patients with unexplained infertility undergoing controlled ovarian stimulation (COS) for IVF/ICSI.
Infertile female patients with normal ovarian reserve will be treated according to clinical practice and the difference between expected (through AFC) and retrieved oocytes will be assessed in relation to use of resveratrol.
Female age 18-40 years
Female BMI 18-30 kg/m2
normal menstrual cycles (26-35 days)
duration of infertility at least 18 months
≥15 cigarettes per day at least in one of the partners
irregular menstrual cycles
poor ovarian response (on the basis of the "Bologna" Criteria)
inaccessible ovaries
Parallel
Resveratrol-based multivitamin supplement
Dietary supplementNatural polyphenol and vitamins
Folic acid
Dietary supplementSupplementation with folic acid at the standard dosage of 0.4 mg/die
IVF/ICSI
Procedure/SurgeryIn vitro fertilization/IntraCytoplasmic Sperm Injection
Follitropin Alfa
DrugControlled Ovarian Stimulation
Ganirelix Acetate 0.5 MG/ML [Fyremadel]
DrugGnRH Antagonist
hCG 10.000 IU or triptorelin 0,3 mg, subcutaneously
DrugFor the induction of oocyte maturation
FORT (Follicle Output Rate)
It is defined as the ratio of pre-ovulatory follicle (≥ 16 mm in diameter) count (PFC) on the day of induction of oocyte maturation and the antral follicle count at baseline, multiplied by 100 (higher values indicate a better outcome).
FOI (Follicle to Oocyte Index)
It is defined by the ratio between the total number of oocytes collected at oocyte pick up and the number of antral follicles at baseline, multiplied by 100. FOI ≤ 50% is considered low (range 0-100%).
The number of mature oocytes
The number of oocytes which have completed the metaphase-II division
OSI (Ovarian Sensitivity Index)
It is defined by the ratio between the number of retrieved oocytes and total dose of gonadotropins administered, multiplied by 1000.
Fertilization rate
The number of embryos obtained after the oocyte insemination.
Cumulative Clinical Pregnancy Rate
It is defined by the ratio between the number of clinical pregnancies (gestational sacs with a fetal heartbeat detected at ultrasound at 7th week of amenorrhea) and the total number of embryo transfers (fresh + frozen) carried out per each patient.
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