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.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
Publications
- Results 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.
- Results Han Y, Luo H, Wang H, Cai J, Zhang Y. SIRT1 induces resistance to apoptosis in human granulosa cells by activating the ERK pathway and inhibiting NF-kappaB signaling with anti-inflammatory functions. Apoptosis. 2017 Oct;22(10):1260-1272. doi: 10.1007/s10495-017-1386-y.
- Results May-Panloup P, Chretien MF, Malthiery Y, Reynier P. Mitochondrial DNA in the oocyte and the developing embryo. Curr Top Dev Biol. 2007;77:51-83. doi: 10.1016/S0070-2153(06)77003-X.
- Results Ortega I, Duleba AJ. Ovarian actions of resveratrol. Ann N Y Acad Sci. 2015 Aug;1348(1):86-96. doi: 10.1111/nyas.12875.
- Results Ragonese F, Monarca L, De Luca A, Mancinelli L, Mariani M, Corbucci C, Gerli S, Iannitti RG, Leonardi L, Fioretti B. Resveratrol depolarizes the membrane potential in human granulosa cells and promotes mitochondrial biogenesis. Fertil Steril. 2021 Apr;115(4):1063-1073. doi: 10.1016/j.fertnstert.2020.08.016. Epub 2021 Jan 22.
- Results Guideline Group on Unexplained Infertility; Romualdi D, Ata B, Bhattacharya S, Bosch E, Costello M, Gersak K, Homburg R, Mincheva M, Norman RJ, Piltonen T, Dos Santos-Ribeiro S, Scicluna D, Somers S, Sunkara SK, Verhoeve HR, Le Clef N. Evidence-based guideline: unexplained infertilitydagger. Hum Reprod. 2023 Oct 3;38(10):1881-1890. doi: 10.1093/humrep/dead150.
- Results Cox CM, Thoma ME, Tchangalova N, Mburu G, Bornstein MJ, Johnson CL, Kiarie J. Infertility prevalence and the methods of estimation from 1990 to 2021: a systematic review and meta-analysis. Hum Reprod Open. 2022 Nov 12;2022(4):hoac051. doi: 10.1093/hropen/hoac051. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ganirelix | Protein / enzyme biologic | 0.25 mg | — |
| Comparator | Gonal-f | Protein / enzyme biologic | — | — |
| Background | Gonasi HP | Unknown | 10000 iu | Subcutaneous |
| Comparator | Triptorelin | Other / unclassified | 0.3 mg | Subcutaneous |