Antioxidant Treatment and the Chance to Conceive in Men Seeking Fertility Care: The SUMMER Randomized Clinical Trial
de Ligny WR, de Bruin JP, Smits RM, Goovaerts IGF
Published in JAMA Network Open
Methodology
Multicentre double-blind placebo-controlled randomized clinical trial in 21 Dutch fertility centres; daily multi-antioxidant tablet (betaine, L-cystine, niacin, zinc, B6, B2, folic acid, B12) for 6 months; intention-to-treat analysis
Key Findings
Ongoing pregnancy within 6 months did not differ between antioxidant and placebo (33.8% vs 37.5%; AOR 0.85, 95% CI 0.66-1.09; P = .20). Between months 4 and 6 the antioxidant group had a significantly lower ongoing pregnancy rate (15.5% vs 21.5%; AOR 0.66, 95% CI 0.47-0.94). No differences in semen parameters or DNA fragmentation.
Conclusions
A widely used multi-antioxidant supplement did not improve conception rates in men seeking fertility care, and the investigators do not support its use.
Limitations
Single fixed formulation and dose; unselected for oxidative stress status; subgroup timing analysis exploratory
Supplements Studied
Ongoing pregnancy rate within 6 months was not significantly different between the 2 groups (adjusted odds ratio [AOR], 0.85 [95% CI, 0.66-1.09]; P = .20)
The antioxidant supplement (Impryl) ... contained betaine (200 mg), L-cystine (200 mg), niacin (16 mg), zinc (10 mg), vitamin B6 (1.4 mg), vitamin B2 (1.4 mg), folic acid (400 µg), and vitamin B12 (2.5 µg)
Outcomes Measured
Ongoing pregnancy rate within 6 months was not significantly different between the 2 groups (193 of 571 [33.8%] vs 208 of 555 [37.5%]; adjusted odds ratio [AOR], 0.85 [95% CI, 0.66-1.09]; P = .20)
Study Details
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