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Coenzyme Q10 treatment in infertile men with idiopathic asthenozoospermia: a placebo-controlled, double-blind randomized trial

Giancarlo Balercia, Eddi Buldreghini, Arianna Vignini, Luca Tiano, Francesca Paggi, Salvatore Amoroso, Giuseppe Ricciardo-Lamonica, Marco Boscaro, Andrea Lenzi, GianPaolo Littarru
Fertility and Sterility 2009 91(5):1785-1792

Bibliography

PubMed
PMID 18395716
Funding
A specific study funding statement was not identified in the accessible PubMed record checked during this audit.
Competing interests
A specific conflict-of-interest statement was not identified in the accessible publication record checked during this audit.

Study snapshot

DesignPlacebo-controlled double-blind randomized trial
ModelPlacebo-controlled, double-blind randomized trial in infertile men with idiopathic asthenozoospermia, including treatment and post-treatment follow-up.
Sample60 men were randomized; 55 completed the protocol according to the published trial report.
InterventionCoQ10 200 mg/day versus placebo. Protocol: 1-month run-in, 6 months of treatment, then 3 months of follow-up.
Duration1-month run-in + 6-month treatment + 3-month follow-up.
EndpointsSperm motility and kinetic parameters; Semen concentration and morphology; CoQ10 and ubiquinol in seminal plasma; CoQ10 and ubiquinol in spermatozoa; Responder analysis; Post-treatment follow-up

What the study showed, in plain terms

This double-blind randomized trial tested CoQ10 200 mg/day for six months in men with idiopathic asthenozoospermia, followed by three months off treatment. The study measured both semen parameters and CoQ10/ubiquinol concentrations in seminal plasma and sperm cells.

CoQ10 supplementation significantly increased CoQ10 and ubiquinol concentrations in seminal plasma and spermatozoa and improved sperm motility/kinetic measures. Men with lower baseline motility and lower CoQ10 status were more likely to be classified as responders.

The trial supports a biological and semen-kinetic signal, but semen parameters are surrogate fertility outcomes. The study did not establish improved spontaneous pregnancy, live birth or time-to-pregnancy, and the sample was small.

Key findings

CoQ10 exposure: seminal-plasma and sperm-cell CoQ10/ubiquinol concentrations increased significantly during treatment.

Sperm kinetics: sperm motility and kinetic features improved significantly with CoQ10 compared with baseline/control, forming the main positive clinical-laboratory signal.

Responder analysis: lower baseline sperm motility and lower baseline CoQ10 status were associated with a greater probability of response.

Design: 200 mg/day for six months, followed by three months of follow-up; 60 randomized and approximately 55 completing the protocol.

Clinical scope: the trial measured semen quality, not pregnancy or live-birth outcomes.

What this study can and cannot tell us

Small trial, with about 55 completers from 60 randomized men.

Primary benefits were semen and biochemical surrogate outcomes; improvement in motility does not guarantee conception or live birth.

The responder analysis is exploratory and can be unstable in a small dataset.

The accessible publication record did not provide enough detail to reconstruct all adverse events, allocation-concealment procedures or the exact finished-product formulation; those values are not inferred.

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