Randomized, Placebo-Controlled, Double-Blind, Multi-Centre Pilot Study to Investigate the Effect of AM019016 on male spermatogenesis in Subjects with diagnosed unspecific (idiopathic) subfertility

INTERVENTION: Intervention 1: Verum Group: Taking AM019016 (verum), dietary food, 3 capsules once a day to a meal with some liquid, oral intake, over 12 weeks. Ingredients: Vitamin D, E, C, B12, B6, B2, Folic Acid, L‐Carnithine, L‐Arginine, Coenzyme Q10, Zinc, Selenium, Beta Carotene, Copper, Pigrafert (combination of pine bark, grape seed, green tea extract). Intervention 2: Placebo group: Taking AM019016 (placebo), 3 capsules once a day with a meal with some liquid, oral intake, over 12 weeks. Ingredients Placebo: maltodextrin, release agent magnesium salts of feed fatty acids and dye E171 and hydropropylmethylcellulose in the capsule shell. Free of gluten and lactose. CONDITION: unspecific subfertility in men # childlessness PRIMARY OUTCOME: Parameters for the assessment of the benefit by preparation and evaluation of spermograms according to the WHO criteria (2010, 5th edition):; ; Change in progressive motility (visit 1 vs. visit 2) ; Change of sperm concentration (visit 1 vs. visit 2) Change of sperm morphology (visit 1 vs. Visite 2) Change of sperm total (Visite 1 vs. Visite 2) ; Change in total motility (visit 1 vs. Visite 2) ; Change of the ejaculate volume (visit 1 vs. Visite 2) ; Occurrence of pregnancy during the study and about 3 months after visit 2 ; Global evaluation of the benefit by the physician (to visit 2) on a scale with the four assessment points "very good", "good", "moderate" and "bad". SECONDARY OUTCOME: Parameters for the assessment of tolerability: ; Adverse events and serious adverse advents during the clinical trial ; ; Global evaluation of the tolerability by the physician and subjects using a scale with the four assessment points "very good", "good", "moderate" and "bad" at final visit. INCLUSION CRITERIA: 1. Men with existing unfulfilled child wish 2. Uspecific (idiopathic) subfertility diagnosed by an already existing sperm analysis (may not be older than four weeks) and whilst observing a sexual abstinence period of at least 2 days to a amaxium of 7 days; according to WHO reference values (2010, 5th Edition): ‐ < 39 million total number of spermatozoa per ejaculate sample and / or ‐ < 32 % progressive motile spermatozoa 4. Readiness to comply with at least 2 to a maximum of 7 Days of sexual abstinence before creating a Spermogram 5. Consent to take a dietary food for three months A written consent of the subject after written and oral enlightenment by the doctor about nature, scope, importance, potential benefits and possible risks of the clinical trial is the prerequisite for participation in the clinical trial.