Clinical Trial Disproves Claims That Antioxidant Supplement Boost Male Fertility

Marketed arsenic a fertility booster, nan antioxidant Impryl showed nary use successful a ample Dutch trial, and moreover reduced gestation rates astatine nan captious curen window, challenging supplement claims.

Trial: Antioxidant Treatment and nan Chance to Conceive successful Men Seeking Fertility Care. Image Credit: ADragan / Shutterstock

In a caller study published in JAMA Network Open, researchers conducted a large, multicenter, randomized objective proceedings (RCT) known arsenic 'SUMMER' to analyse nan outcomes of celebrated antioxidants marketed for improving antheral fertility.

The study (conducted successful nan Netherlands betwixt 2018 and February 2024, pinch follow-up completed successful December 2024) collated information from 1,171 big (18-50 years) men randomly assigned to either lawsuit (antioxidant supplementation) aliases power (placebo) cohort. The supplement tested was Impryl, containing betaine 200 mg, L-cystine 200 mg, niacin 16 mg, zinc 10 mg, vitamin B6 1.4 mg, vitamin B2 1.4 mg, folic acerb 400 μg, and vitamin B12 2.5 μg.

Study findings aft six months of follow-up revealed that nan regular antioxidant supplement did not amended nan ongoing gestation complaint compared to nan placebo. Notably, during nan optimal curen effect window, observed gestation rates were importantly little successful nan antioxidant group, suggesting that supplementation whitethorn evoke counterproductive outcomes. Consequently, this investigation recommends against regular antioxidant supplement usage successful men seeking fertility care.

Background

Infertility is simply a increasing world concern, pinch nan World Health Organization (WHO 2023) highlighting that ~17.5% of nan big organization faces difficulties conceiving. Male facet infertility, gestation difficulties attributed to harm aliases functional degradation of nan antheral reproductive system, is now known to relationship for ~50% of each infertility cases, but nan mechanisms underpinning these detrimental effects stay poorly understood.

A cardinal hypothesized culprit successful this relationship is oxidative stress, a information wherein damaging molecules called 'reactive oxygen type (ROS)' generated done regular physiological functioning, overwhelm nan body's earthy antioxidant defenses, causing terrible harm to DNA and sperm membranes, thereby impairing their regular function. Excessive antioxidant usage tin besides induce reductive stress, different imaginable pathway of harm.

Consequently, nan marketplace for over-the-counter antioxidant supplements has surged substantially successful caller years, pinch today's markets progressively saturated pinch products claiming to boost antheral fertility by neutralizing these harmful ROS. These supplements often incorporate vitamins and different antioxidant compounds for illustration L-cystine, zinc, and folic acid.

Unfortunately, while nan mentation underlying these physiological benefits is scientifically plausible, coming objective grounds remains conflicting, chiefly owed to these studies' mini sample sizes and methodological weaknesses. A large, well-designed, placebo-controlled proceedings is urgently required to find if these celebrated supplements activity and what their imaginable broadside effects whitethorn be.

About nan study

The coming study intends to reside this knowledge request by leveraging information from nan SUMMER trial, a large-scale, investigator-initiated, double-blind, placebo-controlled randomized objective proceedings (RCT) conducted successful nan Netherlands (21 hospitals and fertility clinics) betwixt May 2018 and December 2024.

The study enrolled 1,171 big men (aged 18 to 50) who were actively seeking fertility support (e.g., intrauterine insemination, intracytoplasmic sperm injection [ICSI], successful vitro fertilization [IVF]) pinch their partners. Cumulative gestation was assessed wrong 9 months of randomization. Experimental interventions were carried retired for six months. Participants included successful nan study were randomly assigned to either nan lawsuit (combination antioxidant supplementation) aliases power (equivalent placebo) cohort.

The superior result of liking was nan complaint of ongoing gestation (defined arsenic a viable gestation astatine 12 weeks of gestation) conceived wrong six months of starting nan treatment. The study additionally investigated a scope of secondary outcomes, including changes successful semen parameters (like sperm attraction and motility), DNA fragmentation, and gestation rates astatine different clip points.

Study findings

The coming study revealed that, aft six months of antioxidant aliases placebo supplementation, nary important differences successful nan complaint of ongoing gestation betwixt cases and controls could beryllium established. Specifically, ongoing gestation rates were estimated astatine 33.8% (193 of 571 men) successful nan antioxidant group, compared to 37.5% (208 of 555 men) successful nan placebo group (Adjusted Odds Ratio [AOR], 0.85, 95% CI, 0.66-1.09).

Secondary result analyses identified an moreover much troubling inclination crossed each investigated variables. While astir variables demonstrated neutral outcomes, erstwhile looking specifically astatine nan model of optimal curen effect, from 4 to 6 months, accounting for nan 72-day rhythm of sperm production, ongoing gestation complaint was importantly little successful nan men taking nan antioxidant supplement than successful those taking nan placebo: 15.5% versus 21.5% (AOR, 0.66, 95% CI, 0.47-0.94, P = .02).

Among couples undergoing IVF aliases ICSI, gestation aft ovum pickup and aft caller embryo transportation was importantly little pinch antioxidant curen compared pinch placebo, while nary quality was observed aft frozen-thawed embryo transfer. Fertilization and embryo utilization rates did not disagree betwixt groups.

Semen parameters including volume, concentration, motility, and TMSC reclassification did not disagree betwixt groups. In a subgroup, sperm DNA fragmentation showed nary between-group differences, but sperm vitality decreased wrong nan antioxidant group compared pinch baseline (62.7% to 54.9%).

Adverse events were uncommon and akin betwixt groups, though adherence was humble astatine 58%.

Live commencement and immoderate obstetric aliases neonatal outcomes were not yet disposable astatine publication. The authors released results early because of a imaginable adverse awesome and ethical considerations.

Conclusions

The coming study remains 1 of nan first to explicitly trial nan associations betwixt antioxidant supplementation and antheral fertility outcomes wrong a large, RCT framework. Study findings revealed that, contrary to trading claims and celebrated belief, antioxidant supplementation whitethorn not amended antheral fertility outcomes.

In contrast, study findings demonstrated that antioxidant supplementation whitethorn importantly little nan gestation complaint observed during nan captious (4-6 months) play erstwhile nan curen should person been astir effective. These findings, mixed pinch IVF/ICSI subgroup results and adverse vitality changes, be aware against regular usage of this antioxidant supplement for men seeking fertility care.

The proceedings received an unrestricted assistance and study medicine from Goodlife Pharma BV, nan developer and marketer of Impryl, though nan sponsor had nary domiciled successful study design, information analysis, interpretation, aliases publication decisions.