Idiopathic (Oligo)±(atheno)±(terato) spermia associated to male infertility. Urological and Genital Diseases
Conditions
Interventions
This study consists of two arms. Participants will be randomly allocated to one of these arms.
The patients of the first arm will be treated with active drug: L. paracasei B21060 + arabinogalattan an
Sponsors
Gynepro Medical
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Infertile (oligo)±(atheno)±(terato) spermic infertile males aged 20-50 2. Normal sperm appearance, consistency, liquefaction, volume, and pH
Exclusion criteria
Exclusion criteria: 1. Azoospermia 2. Seminal white blood cell concentration greater than 1 million/ml and/or a positive seminal cultural analysis or 3. Positive urethral swab chlamydia test 4. Drug, tobacco, or alcohol abuse 5. Ongoing medical treatment 6. Previous cancer radiotherapy or chemotherapy 7. Palpable varicocele 8. X-ray exposure in the previous 8 months 9.Y chromosome microdeletion 10. Karyotype alterations 11. Presence of female factors for infertility 12. Female partner age > 35 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sperm concentration, sperm motility and percentage of typical sperm forms, measured at baseline and at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of biochemical pregnancies (detected by measuring serum ß-hCG on at least two occasions 14 days after the last expected menstruation) 2. The numbers of clinical pregnancies (defined as detectable heart activity) The differences between active drug or placebo group were assessed using the Mann–Whitney U test. | — |
Countries
Italy
Contacts
Public ContactCarlo Maretti
Outcome results
None listed