Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility

Summary

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.

Conditions

• Unexplained Infertility

Interventions

DIETARY_SUPPLEMENT

Resveratrol-based multivitamin supplement

Natural polyphenol and vitamins

DIETARY_SUPPLEMENT

Folic acid

Supplementation with folic acid at the standard dosage of 0.4 mg/die

PROCEDURE

IVF/ICSI

In vitro fertilization/IntraCytoplasmic Sperm Injection

DRUG

Follitropin Alfa

Controlled Ovarian Stimulation

DRUG

Ganirelix Acetate 0.5 MG/ML [Fyremadel]

GnRH Antagonist

DRUG

hCG 10.000 IU or triptorelin 0,3 mg, subcutaneously

For the induction of oocyte maturation

Sponsors & Collaborators

• Andros Day Surgery Clinic

  lead OTHER

Principal Investigators

• Adolfo Allegra, MD · ANDROS Day Surgery Clinic Palermo, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Italy

Study Locations