[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.

[The use of nutrient complexes in idiopathic male infertility associated with asteno- and/or teratozoospermia: the search of predictors of treatment efficiency (preliminary results)].

BACKGROUND: Nutrient complexes (dietary supplements) containing various vitamins, minerals, enzymes are popular substances for treatment of male infertility. However, the use of such complexes often does not lead to an improvement of ejaculate analysis and the restoration of fertility. AIM: To determine the predictors of efficiency of treatment with a complex of nutrients. MATERIAL AND METHODS: An open, uncontrolled study which included 102 men from infertile couples aged 25-45 years with idiopathic asteno-, and/or teratozoospermia was conducted. All man received the complex of nutrients (4 capsules of 410 mg per day) containing L-arginine (720 mg), L-carnitine (240 mg), L-carnosine (92 mg), coenzyme Q10 (10 mg), glycyrrhetinic acid (6 mg), zinc (4,8 mg), vitamin (3,2 mg), vitamin (0,36 mg), selenium (0,034 mg), which is from 12% to 80% of recommended level of daily intake for these substances. The ejaculate analysis was done in accordance to WHO recommendations, including the assessment of the production of reactive oxygen species (ROS). RESULTS: After 3 months of treatment the proportion of sperm cells with progressive motility increased in 59% patients in the average by 4 % (<0.05) due to an increase in the proportion of rapidly progressive sperms with grade "A" motility by 4 % (<0,05) and a decrease in the proportion of non-progressive sperms (-2 %; <0.05). The improvement was more often observed in patients with baseline lower sperm motility (<0,05) and had phasic dependence on the ROS level. It was more pronounced (+24 % in relative values for motility "A"; <0.05) in patients with moderate elevation of ROS level (2-4 IU), and insignificant at the normal (< 2 IU) and marked elevated (4-7 >7 IU) ROS level. The standardized effect with an increase of ROS for motile spermatozoa of category A was 0.16, 0.47, 0.34 0.22, respectively, i.e., it was weak in all cases. The changes of sperm concentration and morphology were insignificant (>0.05), but the improvement of sperm morphology was more often observed in patients with pathologic forms greater than 95 % (<0.05). CONCLUSION: The increase in the proportion of sperm cells with progressive motility while taking nutrient complex had dependence on the baseline level of oxidative stress and it was more pronounced in patients with moderate elevation of ROS level. The further, more powerful studies to assess the influence of dietary of this supplement on the other ejaculate indicators.

[Using L- and acetyl-L-carnintines in combination with clomiphene citrate and antioxidant complex for treating idiopathic male infertility: a prospective randomized trial].

The most common cause of male infertility is idiopathic oligo-, and or astheno-, and /or teratozoospermia. In such cases, anti-estrogens, antioxidants (vitamins and trace elements) or carnitines are used, but the evidence on their effectiveness is inconsistent; there are currently no published studies exploring their concurrent use. AIM: To investigate the efficacy and safety of the L- and acetyl-L-carnitine complex, vitamins A, E, C, selenium, zinc and other antioxidants ("SpermActin" + "More than vitamins") in combination with clomiphene citrate (CC) in managing male idiopathic infertility in the form of oligo, and/or astheno-, and/or teratozoospermia. MATERIALS AND METHODS: The study comprised 173 men from infertile couples aged 25-45 years who were divided into two groups - the study group (n=88) and control group (n=85). All the patients were examined according to the WHO recommendations. Patients of the study group received L-carnitine fumarate (1 g), acetyl-L-carnitine (0.5 g) twice daily, a complex of vitamins and microelements and CC 25 mg twice daily orally. Patients of the control group were administered the same dosages of CC and a complex of vitamins. Ejaculate was evaluated before and after 3-4 months of treatment. Six months after the start of treatment, information about the onset or absence of pregnancy over the last six months was collected via telephone or online survey. RESULTS: Co-administration of L- and acetyl-L-carnitines concurrently with CC and antioxidant complex (vitamins and minerals) in patients with idiopathic oligo- and/or asteno- and/or teratozoospermia provides some additional positive effect on the concentration of spermatozoa, more pronounced in patients with multiple impaired semen parameters - oligoasthenoteratozoospermia, but does not improve the morphology, progressive sperm motility and pregnancy rates compared to patients receiving basic treatment.