Spermotrend in the Treatment of Male Infertility

Catalysis SL86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Male Infertility

Interventions

PlaceboDIETARY_SUPPLEMENT

One Placebo tablet (Orally administered) twice a day, for 12 weeks.

SpermotrendDIETARY_SUPPLEMENT

One Spermotrend tablet (Orally administered) twice a day, for 12 weeks

Eligibility

Sex: MALEMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, Cuba

Outcomes

Primary Outcomes

Parameters of seminal analysis at weeks 24

Time frame: 24 weeks

Secondary Outcomes

Fertilization achievement

Time frame: 24 weeks

Presence of mild or severe adverse effects

Time frame: 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.