Male Infertility
Conditions
Keywords
Dietary supplement, male infertility, spermatogenesis
Brief summary
The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.
Interventions
DIETARY_SUPPLEMENTPlacebo
One Placebo tablet (Orally administered) twice a day, for 12 weeks.
DIETARY_SUPPLEMENTSpermotrend
One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male infertility unrelated to major testicular conditions * Must have at least one altered seminal parameter. * Signed informed consent
Exclusion criteria
* Hydrocele, varicocele, orchitis, epididymitis, irradiation or Chemotherapy. * Previously treated and cured testicular condition. * Non-transmissible chronic diseases * Use of antioxidant agents within 6 months. * Use of vitamins within 6 months. * Use of anti-inflammatory drugs within 6 months. * Use of hormones prescribed by an andrologist within 6 months * Positive serology/HIV * Leukocytospermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parameters of seminal analysis at weeks 24 | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Fertilization achievement | 24 weeks |
| Presence of mild or severe adverse effects | 24 weeks |
Countries
Cuba
Outcome results
None listed