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Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility
Sponsor: Andros Day Surgery Clinic
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-06-01
Completion Date
2025-12-31
Last Updated
2024-07-01
Healthy Volunteers
No
Conditions
Interventions
Resveratrol-based multivitamin supplement
Natural polyphenol and vitamins
Folic acid
Supplementation with folic acid at the standard dosage of 0.4 mg/die
IVF/ICSI
In vitro fertilization/IntraCytoplasmic Sperm Injection
Follitropin Alfa
Controlled Ovarian Stimulation
Ganirelix Acetate 0.5 MG/ML [Fyremadel]
GnRH Antagonist
hCG 10.000 IU or triptorelin 0,3 mg, subcutaneously
For the induction of oocyte maturation
Locations (1)
ANDROS Day Surgery Clinic
Palermo, Italy