[Hydrophilic and lipophilic nutrients for the treatment of male idiopathic infertility: a randomized, comparative, open-label, multicenter, prospective, controlled study].

Introduction: the efficiency of nutrient therapy for idiopathic male infertility remains controversial. In particular, it is not unclear if hydrophilic or lipophilic nutrients are more effective.

Aim: to compare the efficiency of a complex containing hydrophilic components (L-carnitine, zinc, selenium, vit. C, etc.) with a complex of lipophilic nutrients (docosahexaenoic and other omega-3 acids, vitamin E) in men with idiopathic subfertility.

Materials And Methods: a randomized, comparative, open-label, prospective, controlled, multicenter study was carried out. A total of one hundred and sixty patients with idiopathic oligo-, and/or astheno-, and/or teratozoospermia aged 18-45 years were randomized into three groups. In the group 1, patients received a complex of mainly hydrophilic nutrients (BESTFertil dietary supplement, 4 capsules per day), while in group 2 lipophilic nutrients (dietary supplement "BrudiPlus", 3 capsules per day) were prescribed. In the group 3 (control) patients didnt receive any treatment. All participants were given recommendations for a healthy lifestyle. Sperm analysis, sperm DNA fragmentation, and achievement of pregnancy were evaluated at baseline and after 3 months.

Results: 27 patients did not have a follow-up visit due to pregnancy achievement or other reasons, or were excluded from the study since pyospermia was detected or compliance was poor. Patients of group 1 (n=46) who remained in the protocol had an increase in sperm concentration by 16 million/ml (+ 41% vs. baseline; p=0.046), in comparison to 3 million/ml (+ 7% vs. baseline; p>0.05) in group 2 (n=45) and a slight decrease by 0.5 million/ml in the group 3 (n=42; - 1.2% vs. baseline; p>0.05). Positive changes were seen in 63, 58 and 52% of cases, respectively (in all cases, p>0.05). DNA fragmentation in all groups changed in similar fashion. In group 1 (n=31) it decreased by 6% (-33% vs. baseline; p=0.002), compared to - 5% in group (n=29; -29% vs. baseline; p=0.002) and -11% in group 3 (n=15; -48%; p<0.001). Positive changes were seen in 65% (p>0.05), 79% (p<0.01) and 73% (p>0.05) cases, respectively. Over a 3-month period, other sperm indices in all groups changed in different directions and there was no significant difference (p>0.05). There were 6 pregnancies in group 1 and 2 (11%), compared to 2 pregnancies in group 3 (4%; p>0.05). Intergroup comparison between the groups for all the values assessed did not reveal significant differences (p>0.05).

Conclusions: 3-month therapy with hydrophilic or lipophilic antioxidant nutrients in men with idiopathic oligo-, and/or astheno- and/or teratozoospermia does not have significant effect on sperm analysis, sperm DNA fragmentation, and pregnancy rate. There is an urgent need to carry out additional comparative randomized trials to clarify indications for nutritional therapy. Statistical power of maximum 0.69 does not allow to exclude the type II error, non-rejection of a false null hypothesis.