Protocol for antioxidant therapy in couples of advanced reproductive age in a multicentre prospective observational cohort study — ASN Events
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Protocol for antioxidant therapy in couples of advanced reproductive age in a multicentre prospective observational cohort study (#533)

Jane McDonnell 1 , Pru Sweeten 1 , Jo Master 1 , Molly Toogood 1 , Tessa Morgan 1 , Helen Baudoin 1 , Rebecca Deans 1 , Rachael Rodgers 1 , Harleen Kaur 1 , Shannon HK Kim 1 , Nicole Kellow 2 , Devora Lieberman 3 , Michael Costello 1 , Geoffry De Iuliis 4 , Robert Aitken 4 , Meurig Gallagher 5 , Jackson Kirkman-brown 5 , Roger Hart 6 , Fabrizzio Horta 1
  1. Fertility & Research Centre, UNSW Sydney, Randwick, NSW, Australia
  2. Department of Nutrition, Dietetics & Food, Monash University, Melbourne, VIC, Australia
  3. Reproductive Medicine, City Fertility, Sydney, NSW, Australia
  4. Priority Research Centre for Reproductive Science, The University of Newscatle , Newcastle, NSW, Australia
  5. University of Birmingham, Birmingham, UK
  6. Division of Obstetrics and Gynaecology, The University of Western Australia, Perth, WA, Australia

Background

Idiopathic male infertility is diagnosed when abnormal semen parameters are present without an identifiable cause. Oxidative stress can impair sperm function and DNA integrity, while sperm DNA damage may increase with male age. Although oocytes can repair some paternal DNA damage after fertilisation, this capacity declines with oocyte ageing, potentially increasing its reproductive impact in couples of advanced reproductive age. This study will evaluate the effectiveness and safety of FTC0098, containing pollen extracts, zinc and vitamin E, in couples with idiopathic male infertility and a female partner aged 35 years or older.

Methods

This multicentre prospective observational cohort study uses a pre- and post-treatment design (Clinical trial registration: ACTRN12625001222437). Fifty-five men aged 20–60 years who meet eligibility criteria will receive FTC0098 for 16 weeks. Semen quality, sperm DNA damage, oxidative DNA damage and oxidative stress will be assessed at three time points over 3.5 months. Safety and reproductive outcomes, including clinical pregnancy and live birth, will be obtained from medical records. Analyses will use intention-to-treat and per-protocol approaches. Repeated measures will be evaluated using MANOVA, with generalised mixed models used in exploratory analyses to account for potential confounders. Analyses will be performed using SAS and/or SPSS.

Results

At abstract preparation, ethics approval and recruitment were pending; therefore, participant-level outcome data were unavailable. Prespecified outputs are within-participant changes in semen parameters and sperm health biomarkers, treatment safety, clinical pregnancy and live birth, reported with effect estimates, 95% confidence intervals and p values where appropriate.

Conclusion

This protocol will determine whether adjunct antioxidant therapy is associated with improved sperm quality and molecular markers in couples facing idiopathic male infertility and advanced female reproductive age. The findings will inform future controlled trials and the clinical utility of targeted antioxidant therapy.