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Spermotrend in the Treatment of Male Infertility

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975117
First Posted: September 11, 2009
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Catalysis SL
  Purpose
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 Intervention Phase
Male Infertility Dietary Supplement: Placebo Dietary Supplement: Spermotrend Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

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

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

Estimated Enrollment: 86
Study Start Date: September 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 10, 2009
First Posted: September 11, 2009
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