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Completed

NCT Number: NCT00975117

Spermotrend in the Treatment of Male Infertility

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.

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Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

19 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

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

Spermotrend

Dietary Supplement

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

Primary outcomes

  1. Parameters of seminal analysis at weeks 24

    Time frame: 24 weeks

Secondary outcomes

  1. Fertilization achievement

    Time frame: 24 weeks

  2. Presence of mild or severe adverse effects

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 11, 2009
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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