Study of Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Medicinal Product MediReg®

Inclusion Criteria:

1. Male patients aged 21-60 years at the time of inclusion in the study. 2.Persistent severe disorders of spermatogenesis, manifested as severeoligoasthenoteratozoospermia (OAT)*, non-obstructive azoospermia, high spermDNA fragmentation (30% or more), including those caused by secretoryinfertility according to dynamic control of spermogram (at least 12 months fromthe moment of inclusion in the study).

• "Persistent severe OAT" should be considered as disorders when spermconcentration <5 million/mL, progressively motile sperm <13% and/or totalnumber of progressively motile sperm in the ejaculate (PMPM) <5 million, withthe proportion of normal sperm <1% according to the dynamic control ofspermogram (at least 12 months from the moment of inclusion in the study).

3. inability to conceive against the background of "severe forms" of maleinfertility, not amenable to treatment, including assisted reproductivetechnologies, within 12 months from the moment of diagnosis or refusal touse assisted reproductive technologies.
4. Voluntarily signed Informed consent by the patient to participate in theclinical trial.
5. Willingness of patients and their sexual partners to use reliablecontraceptive methods (combination of at least 2 methods, including 1barrier method, e.g., use of spermicide and condom) from the time ofsigning the informed consent until at least 1 month after completion ofstudy participation.
6. Patient willingness to follow all the requirements of the Protocol.

Exclusion Criteria:

1. Age younger than 21 and older than 60 years at the time of inclusion in thestudy.

2. developmental anomalies of the genitourinary system (according to bladder andkidney ultrasound).

3. surgical interventions on genitourinary organs in the history, except forsurgical interventions associated with assisted reproductive technologies. 4.

4. Systemic diseases requiring administration of corticosteroids, cytostatics,radiation therapy.

5. Inflammatory diseases of the urinary and/or reproductive system. 6. Infectiousdiseases (including STDs) of the urinary and/or reproductive system.

6. Hereditary factors of infertility: (Klinefelter syndrome (all variants),autosomal abnormalities (all variants), carrying the cystic fibrosis gene (allvariants), presence of Y-chromosome microdeletions (all AZF variants),autosomal defects with severe phenotypic abnormalities and infertility (Prader-Willi, Bardet-Biedl, Noonan syndromes, myotonic dystrophy, dominantpolycystic kidney disease, 5-alpha-reductase enzyme deficiency, etc.). д.).

7. Obstructive azoospermia by history or established by screening examination. 9.Positive test for HIV, hepatitis B and C, syphilis. 10. Severe liver failure oractive liver disease (transaminase activity exceeding 5 times the upper limitof the local laboratory norm).

8. Renal dysfunction with serum creatinine levels exceeding 120 µmol/L. 12.Cardiovascular diseases in the history within 6 months before inclusion in thestudy, such as myocardial infarction, angina pectoris, severe ventriculararrhythmia, heart failure (NYHA class II-IV).

9. Neurologic (Parkinson's disease) and/or psychiatric illnesses with a history orestablished by screening examination.

10. Cancer with a history of cancer or as determined by screening examination (asdetermined by OBP and renal ultrasound, bladder ultrasound, prostate TRUS).

11. Hypersensitivity to any of the components of the study drug in the history. 16.Mental illness, severe cognitive impairment, need to take tranquilizers,neuroleptics and/or antidepressants during this study.

12. Severe somatic illnesses that, in the opinion of the investigator, may affectthe patient's safety and ability to comply with the Protocol.

13. A history of drug dependence. 19. Positive urinalysis for psychotropic andnarcotic drugs, psychoactive medications.

14. Intake of more than 10 units of alcohol per week (1 unit of alcohol isequivalent to 1⁄2 liter of beer, 200 ml of wine, or 50 ml of alcohol) or ahistory of alcoholism.

15. Detection of alcohol vapor in breath 22. Participation in another clinicaltrial currently or in the previous 30 days prior to the screening visit.

16. Patient's inability to understand or comply with study procedures or patient'srefusal to cooperate with a particular investigator