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Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.
This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proxeed arm | Active Comparator | Subjects received 2 packets per day for 6 months of supplement (1000 mg of L-carnitine, 725 mg of fumarate, 500 mg of acetyl-L-carnitine, 1000 mg of fructose, 50 mg of citric acid, 50 µg of selenium, 20 mg of coenzyme Q10, 90 mg of vitamin C, 10 mg of zinc, 200 µg of folic acid and 1.5 µg of vitamin B12) |
|
| Placebo arm | Placebo Comparator | Subjects received 2 packets per day for 6 months of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proxeed | Dietary Supplement | Treatment with dietary supplement for male infertility for Proxeed Arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of sperm concentration (millions/ml) on spermogram of infertile men | Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age. | 6 months |
| Evaluation of sperm motility (%) on spermogram of infertile men | Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age. | 6 months |
| Evaluation of sperm normal morphology (%) on spermogram of infertile men | Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pregnancy rate (number) | Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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Double-blind placebo controlled trial
| Placebo | Other | Treatment with placebo for Placebo Arm |
|
| D052801 |
| Male Urogenital Diseases |