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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   19 Years to 60 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 10, 2009
Last Updated: March 6, 2011
Health Authority: Cuba: Institutional Review Board

Keywords provided by Catalysis SL:
Dietary supplement
male infertility
spermatogenesis

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

ClinicalTrials.gov processed this record on July 31, 2014