The association of a probiotic with a prebiotic (Flortec, Bracco) to improve the quality/quantity of spermatozoa in infertile patients with idiopathic oligoasthenoteratospermia: a pilot study.

The hypothesis that the assumption of a probiotic associated with a prebiotic (Flortec, Bracco; one sachet contains: Lactobacillus paracasei B21060 5 × 109 cells + arabinogalctan 1243 mg + oligo-fructosaccharides 700 mg + l-glutamine 500 mg) could improve the quality and quantity of spermatozoa in idiopathic oligoasthenoteratospermia (iAOT) patients to a larger extent than a control substance (starch) was tested. Forty-one patients with no chromosomal aberrations were randomized into two groups: 20 received Flortec, one sachet per day for 6 months, whereas 21 received the control substance. The following data were collected: clinical history, scrotal Doppler scans, Y microdeletion, karyotype and cystic fibrosis screens, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), testosterone (T), and prolactin (PRL) levels, and two semen analyses. Both the Flortec and the starch groups underwent two semen analyses and one FSH, LH, T, E2, and PRL measurement in the blood, at the beginning of the study, and after 6 months. The comparisons were carried out using a non-parametric (Wilcoxon signed rank) test. The side effects were assessed and compared using the chi-squared test. Group 1 (Flortec) had their sperm count improved: volume of the ejaculate (median from 2.4 to 3.1 mL; p < 0.01), sperm concentration (median: from 15.2 × 106 /mL to 28.3 × 106 /39 mL; p < 0.01), progressive motility (median: from 16.2 to 42.0%; p < 0.01), and the percentage of typical forms (median: from 7 to 16.3%; p < 0.01); in addition, their FSH, LH, and T levels improved (p < 0.01), while those of E2 and PRL did not. Group 2 (control substance) had no modification in 42 of the parameters studied. There were no side effects in either group. These data showed that Flortec constitutes a safe therapy for improving the volume of the ejaculate and the quality/quantity of spermatozoa in iOAT patients.

RCT Entities:   Population Interventions Outcomes