Spermotrend in the Treatment of Male Infertility

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00975117
First received: September 10, 2009
Last updated: March 6, 2011
Last verified: March 2011

September 10, 2009
March 6, 2011
September 2009
March 2011   (final data collection date for primary outcome measure)
Parameters of seminal analysis at weeks 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00975117 on ClinicalTrials.gov Archive Site
  • Fertilization achievement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Presence of mild or severe adverse effects [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Spermotrend in the Treatment of Male Infertility
Assessment of the Efficacy of Dietary Supplement 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Male Infertility
  • Dietary Supplement: Placebo
    One Placebo tablet (Orally administered) twice a day, for 12 weeks.
  • Dietary Supplement: Spermotrend
    One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
  • Experimental: Spermotrend
    Intervention: Dietary Supplement: Spermotrend
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Male
19 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
NCT00975117
CAT-0905-CU
Yes
Miguel Aguilar Charara, "Ramón González Coro" Gynecologic and Obstetric Hospital
Catalysis SL
Not Provided
Principal Investigator: Miguel Aguilar Charara, MD "Ramón González Coro" Gynecologic and Obstetric Hospital
Catalysis SL
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP