Spermotrend in the Treatment of Male Infertility

Last updated: March 6, 2011
Sponsor: Catalysis SL
Overall Status: Completed

Phase

3

Condition

Infertility

Hypogonadism

Men's Health

Treatment

N/A

Clinical Study ID

NCT00975117
CAT-0905-CU
  • Ages 19-60
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male infertility unrelated to major testicular conditions

  • Must have at least one altered seminal parameter.

  • Signed informed consent

Exclusion

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

Study Design

Total Participants: 86
Study Start date:
September 01, 2009
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • "Ramón González Coro" Gynecologic and Obstetric Hospital

    Havana, 10400
    Cuba

    Site Not Available

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