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Spermotrend in the Treatment of Male Infertility

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ClinicalTrials.gov Identifier: NCT00975117
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : March 8, 2011
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Male Infertility Dietary Supplement: Placebo Dietary Supplement: Spermotrend Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
Study Start Date : September 2009
Primary Completion Date : March 2011
Study Completion Date : March 2011


Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
One Placebo tablet (Orally administered) twice a day, for 12 weeks.
Experimental: Spermotrend Dietary Supplement: Spermotrend
One Spermotrend tablet (Orally administered) twice a day, for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. Parameters of seminal analysis at weeks 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Fertilization achievement [ Time Frame: 24 weeks ]
  2. Presence of mild or severe adverse effects [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975117


Locations
Cuba
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Miguel Aguilar Charara, MD "Ramón González Coro" Gynecologic and Obstetric Hospital
More Information

Responsible Party: Miguel Aguilar Charara, "Ramón González Coro" Gynecologic and Obstetric Hospital
ClinicalTrials.gov Identifier: NCT00975117     History of Changes
Other Study ID Numbers: CAT-0905-CU
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by Catalysis SL:
Dietary supplement
male infertility
spermatogenesis

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female