Spermotrend in the Treatment of Male Infertility

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Male Infertility

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Spermotrend

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975117

CAT-0905-CU

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: Male

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

Spermotrend

Experimental group

Treatment:

Dietary Supplement: Spermotrend