Use of carnitine therapy in selected cases of male factor infertility: a double-blind crossover trial

Andrea Lenzi; Francesco Lombardo; Paolo Sgrò; Pietro Salacone; Luisa Caponecchia; Franco Dondero; Loredana Gandini

doi:10.1016/s0015-0282(02)04679-4

Male Fertility · Male Factor Treatment

Use of carnitine therapy in selected cases of male factor infertility: a double-blind crossover trial

Lenzi A, Lombardo F, Sgrò P, Salacone P, Caponecchia L, Dondero F, Gandini L

Published February 6, 2003 Fertility and Sterility, 79(2), 292-300

DOI 10.1016/s0015-0282(02)04679-4 PMID 12568837

RRM Academy Synopsis

L-carnitine raised sperm motility more than placebo in selected men

In a placebo crossover trial of 100 men with mildly low sperm counts, L-carnitine improved sperm motility and concentration more than placebo once five men were excluded. Eighty-six finished. Eight pregnancies occurred, all during carnitine periods.

Key Findings

The trial enrolled 100 infertile men aged 20 to 40 with mildly reduced sperm measures. Eighty-six finished. Men were to take L-carnitine and placebo in two-month periods, with washout periods between.
Across all 172 treatment periods, motility gains favored carnitine without statistical significance. Excluding five outlier men (162 periods), total and forward motility reached P = .04 and P = .05.
After that exclusion, sperm concentration rose more on carnitine (P = .01) and so did sperm linearity (P = .03). Semen volume, sperm velocity and sperm morphology showed no significant change.
Among 55 men with the lowest forward motile sperm per ejaculate, the gain favored carnitine (P = .03). Among 71 men with the lowest per milliliter, it also did (P = .02).
Eight pregnancies occurred, all during carnitine periods: six in the first therapy period and two in the second, in men who took placebo first.

Interpretation

This randomized, double-blind crossover trial lets each man serve as his own comparison. The first analysis of motility percentages in all men showed no significant difference. Significance appeared after the authors excluded five men whose motility fell during washout, then rebounded. Semen measures improved on placebo too. The men had mild defects, and men with varicocele, genital infection or antisperm antibodies were excluded. Pregnancy was a secondary outcome. The authors call for larger, multicenter trials. Grants from Sigma Tau, maker of the carnitine product, supported the work.

RRM Context

Restorative reproductive medicine evaluates both partners, and sperm quality belongs in that evaluation. These men's partners had a female-factor workup with no apparent findings, and men with varicocele, infection or antibodies were screened out first. The trial tested one supplement on semen measures. The paper leaves the cause of these men's reduced sperm counts undetermined.

Our editorial summary of this paper, not the article's abstract.

Abstract

Objective

To determine the efficacy of L-carnitine therapy in selected cases of male factor infertility.

Design

Placebo-controlled, double-blind, crossover trial.

Setting

University tertiary referral center.

Patients

One hundred infertile patients (ages 20-40 years) with the following baseline sperm selection criteria: concentration, 10-20 x 10(6)/mL; total motility, 10%-30%; forward motility, <15%; atypical forms, <70%; velocity, 10-30 micro/s; linearity, <4. Eighty-six patients completed the study.

Interventions

Patients underwent L-carnitine therapy 2 g/day or placebo; the study design was 2 months of washout, 2 months of therapy/placebo, 2 months of washout, and 2 months placebo/therapy.

Main Outcome Measures

Variation in sperm parameters used in the patients selection criteria, in particular, sperm motility. Excluding outliers, a statistically significant improvement in semen quality, greater than after the placebo cycle, was seen after the L-carnitine therapy for sperm concentration and total and forward sperm motility. The increase in forward sperm motility was more significant in those patients with lower initial values, i.e., <5 x 10(6) or <2 x 10(6) of forward motile sperm/ejaculate or sperm/mL.

Conclusions

Based on a controlled study of efficacy, L-carnitine therapy was effective in increasing semen quality, especially in groups with lower baseline levels. However, these results need to be confirmed by larger clinical trials and in vitro studies.

Topics

Male Fertility Male Factor Treatment Medical Management

Male Fertility › Male Factor Treatment › Medical Management

Andrea Lenzi, Francesco Lombardo, Paolo Sgrò, Pietro Salacone, Luisa Caponecchia, Franco Dondero, Loredana Gandini

A Lenzi, F Lombardo, P Sgrò, P Salacone, L Caponecchia, F Dondero, L Gandini

PMID 12568837 12568837 DOI 10.1016/s0015-0282(02)04679-4 10.1016/s0015-0282(02)04679-4 Lenzi et al. 2003, Lenzi 2003

Keywords

Carnitine/therapeutic Use, Cross-Over Studies, Double-Blind Method, Humans, Infertility, Male/drug Therapy, Male, Placebos, Semen/drug Effects/physiology, Sperm Count, Sperm Motility/drug Effects, Spermatozoa/abnormalities/drug Effects, Placebos, Carnitine

Use of carnitine therapy in selected cases of male factor infertility: a double-blind crossover trial

L-carnitine raised sperm motility more than placebo in selected men

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

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Keywords