RecruitingNot ApplicableNCT06481696

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

Randomized, Placebo-controlled, Double-blind, Single-center Trial to Evaluate the Possible Action of Resveratrol in Improving the Outcomes of Controlled Ovarian Stimulation During the IVF/ICSI Cycles in Couples With Unexplained Infertility


Sponsor

Andros Day Surgery Clinic

Enrollment

90 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Folic acid, a drug called Follitropin Alfa, and others for people with unexplained infertility. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTResveratrol-based multivitamin supplement

Natural polyphenol and vitamins

DIETARY_SUPPLEMENTFolic acid

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

PROCEDUREIVF/ICSI

In vitro fertilization/IntraCytoplasmic Sperm Injection

DRUGFollitropin Alfa

Controlled Ovarian Stimulation

DRUGGanirelix Acetate 0.5 MG/ML [Fyremadel]

GnRH Antagonist

DRUGhCG 10.000 IU or triptorelin 0,3 mg, subcutaneously

For the induction of oocyte maturation


Locations(1)

ANDROS Day Surgery Clinic

Palermo, Italy

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NCT06481696


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