Infertility, Male
Conditions
Brief summary
Approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a Test dietary supplement (TDS), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups). Before intake, and 2 and 4 months after the commencement of TDS, all males will have spermogram. After 6-month use of the TDS and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn
Interventions
DIETARY_SUPPLEMENTDietary Supplement with L-carnitine (FertilHom)
1 stick of the TDS (vitamins, trace elements with carnitine) will be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first
DIETARY_SUPPLEMENTControl Dietary Supplement
1 stick of the TDSwill be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first
Sponsors
NATURAmedicatrix Sàrl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent form signed; 2. Age: 21-50; 3. Idiopathic male infertility; 4. Idiopathic oligo- and/or astheno- and/or teratozoospermia; 5. Stated availability throughout the study period and a mobile phone
Exclusion criteria
1. Allergy to any component of the dietary supplement; 2. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility; 3. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility; 4. Inflammatory bowel disease; 5. Known moderate to severe disease of any systems; 6. Known or suspected sexually transmitted diseases; 7. Alcohol or drug addiction of any couple counterpart as suspected by investigator; 8. Difficulty to comprehend study requirements as judged by investigator; 9. Use of any investigational product within the previous 3 months before entering the study; 10. Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of normalization of spermogram | 4 months | None deviation found in spermogram |
Countries
Ukraine
Contacts
Primary ContactSergiy V Gerasymov, MD,PhD
Outcome results
None listed