Biological and clinical effects of a resveratrol-based multivitamin supplement on intracytoplasmic sperm injection cycles: a single-center, randomized controlled trial

Abstract

Background

Resveratrol display’s positive effects on follicle growth and development in preclinical studies while there is scantly information from clinical trials. The aim of this study was to evaluate the biological and clinical impact of a resveratrol-based multivitamin supplement on intracytoplasmatic sperm injection (ICSI) cycles.

Methods

A randomized, single-center controlled trial conducted at the University Center of Assisted Reproductive Technologies involving 101 women infertile women undergoing ICSI cycles was conducted. A pretreatment with a daily resveratrol based nutraceutical was administered to the Study Group; Control Group received folic acid. The primary outcomes were the number of developed mature follicles (>16 mm), total oocytes and MII oocytes recovered, the fertilization rate and the number of cleavage embryos/blastocysts obtained. Secondary endpoints were the duration and dosage of gonadotropins, the number of embryos for transfer, implantation, biochemical, clinical pregnancy rates, live birth and miscarriage rates.

Results

A significantly higher number of oocytes and MII oocytes were retrieved in the Study Group than in Control Group (p = .03 and p = .04, respectively). A higher fertilization rate (p = .004), more cleavage embryos/patient (p = .01), blastocytes/patients (p = .01) and cryopreserved embryos (p = .03) were obtained in the Study Group. No significant differences in biochemical or clinical pregnancy, live birth, and miscarriage rates were revealed, but a trend to a higher live birth rate was revealed in the Study Group.

Conclusions

A 3 months period of dietary supplementation with a resveratrol-based multivitamin nutraceutical leads to better biological effects on ICSI cycles.

Trial registration number

ClinicalTrials.gov registration identifier: NCT04386499

Keywords:

• Resveratrol
• intracytoplasmic sperm injection
• assisted reproductive technologies
• embryo
• oocyte

Acknowledgments

The authors thank S&R Farmaceutici S.p.A [Italy], for kindly providing the resveratrol based multivitamin nutraceutical for our studies. All authors would like to thank Sara Iannitti Pereira for finalizing the English editing and proofreading of our manuscript.

Institutional review board statement

The study design was in accordance with the Helsinki Declaration, conforms to the Committee on Publication Ethics [COPE] guidelines. The study was approved by the Ethical Committee of Aziende Sanitarie della Regione Umbria [n.15188/18/AV] on 20 December 2018 and retrospectively registered in the ClinicalTrials.gov Protocol Registration System (identifier: NCT04386499) on 13 May 2020.

Informed consent statement

Informed consent was obtained from all individual participants included in the study.

Disclosure statement

Sandro Gerli, Chiara Della Morte, Margherita Ceccobelli, Monica Mariani, Alessandro Favilli, and Bernard Fioretti declare they have no financial interests. Alessandro Lanti and Rossana G. Iannitti receive a salary from S&R Farmaceutici. Lucio Leonardi is Executive Director of S&R Farmaceutici S.p.A.

Author contributions

Sandro Gerli, Bernard Fioretti, and Rossana G. Iannitti made substantial contributions to the conception or design of the work; Sandro Gerli, Bernard Fioretti, Rossana G. Iannitti, Chiara Della Morte, Margherita Ceccobelli, and Monica Mariani made substantial contributions to the acquisition, analysis, or interpretation of data; Sandro Gerli, Bernard Fioretti, Rossana G. Iannitti, Alessandro Favilli, Lucio Leonardi, and Alessandro Lanti revised it critically for important intellectual content; All authors approved the version to be published

Data availability statement

All data and materials as well as software application comply with field standards.