Fertility and Sterility
Volume 84, Issue 3 , Pages 662-671, September 2005

Placebo-controlled double-blind randomized trial on the use of l-carnitine, l-acetylcarnitine, or combined l-carnitine and l-acetylcarnitine in men with idiopathic asthenozoospermia

  • Giancarlo Balercia, M.D.

      Affiliations

    • Andrology Unit and Laboratory of Andrology, Endocrinology, Department of Internal Medicine, Polytechnic University of Marche, Ancona, Italy
    • Corresponding Author InformationReprint requests: Giancarlo Balercia, M.D., Endocrinology, Department of Internal Medicine, Umberto I Hospital, Torrette, Via Conca, 60100 Ancona, Italy (FAX: +39-071-887-300).
  • ,
  • Francesco Regoli, Ph.D.

      Affiliations

    • Department of Biology and Genetics, Umberto I Hospital, School of Medicine, Polytechnic University of Marche, Ancona, Italy
  • ,
  • Tatiana Armeni, Ph.D.

      Affiliations

    • Department of Biology and Genetics, Umberto I Hospital, School of Medicine, Polytechnic University of Marche, Ancona, Italy
  • ,
  • Aleardo Koverech, M.D.

      Affiliations

    • Carnitine Research Unit, Sigma Tau, Pomezia, Italy
  • ,
  • Franco Mantero, M.D.

      Affiliations

    • Endocrinology, Department of Medical and Surgical Sciences, University of Padua, Padua, Italy
  • ,
  • Marco Boscaro, M.D.

      Affiliations

    • Andrology Unit and Laboratory of Andrology, Endocrinology, Department of Internal Medicine, Polytechnic University of Marche, Ancona, Italy

Received 13 December 2004; received in revised form 23 March 2005; accepted 23 March 2005.

Objective

To evaluate the effectiveness of l-carnitine (LC) or l-acetyl-carnitine (LAC) or combined LC and LAC treatment in improving semen kinetic parameters and the total oxyradical scavenging capacity in semen.

Design

Placebo-controlled, double-blind, randomized trial.

Setting

Andrology unit, Department of Internal Medicine, Polytechnic University of Marche, Italy.

Patient(s)

Sixty infertile men, ages 20 to 40 years, with the following baseline sperm selection criteria: concentration >20 × 106/mL, sperm forward motility <50%, and normal sperm morphology >30%; 59 patients completed the study.

Intervention(s)

Patients underwent a double-blind therapy of LC 3 g/d, LAC 3 g/d, a combination of LC 2 g/d and LAC 1 g/d, or placebo. The study design was 1 month of run in, 6 months of therapy or placebo, and 3 months of follow-up evaluation.

Main Outcome Measure(s)

Variations in semen parameters used for patient selection, and variations in total oxyradical scavenging capacity of the seminal fluid.

Result(s)

Sperm cell motility (total and forward, including kinetic features determined by computer-assisted sperm analysis) increased in patients to whom LAC was administered both alone or in combination with LC; combined LC + LAC therapy led to a significant improvement of straight progressive velocity after 3 months. The total oxyradical scavenging capacity of the semen toward hydroxyl and peroxyl radicals also increased and was positively correlated with the improvement of kinetic features. Patients with lower baseline values of motility and total oxyradical scavenging capacity of the seminal fluid had a significantly higher probability of responding to the treatment.

Conclusion(s)

The administration of LC and LAC is effective in increasing sperm kinetic features in patients affected by idiopathic asthenozoospemia and improves the total oxyradical scavenging capacity of the seminal fluid in the same population.

Key Words:  Male infertility , carnitine therapy , asthenozoospermia , total scavenging capacity

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 Supported by the Italian Ministry of Universities and Research, the Polytechnic University of Marche, and the Ospedali Riuniti, Umberto I Hospital, Ancona by grants from Sigma Tau srl (Pomezia, Italy). A.K. is the Head of Carnitine Research Unit, Sigma Tau and is responsible for the study design.

PII: S0015-0282(05)01230-6

doi:10.1016/j.fertnstert.2005.03.064

Fertility and Sterility
Volume 84, Issue 3 , Pages 662-671, September 2005