Spermotrend in the Treatment of Male Infertility
Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 8, 2011
March 1, 2011
1.5 years
September 10, 2009
March 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Parameters of seminal analysis at weeks 24
24 weeks
Secondary Outcomes (2)
Fertilization achievement
24 weeks
Presence of mild or severe adverse effects
24 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORSpermotrend
EXPERIMENTALInterventions
One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
Eligibility Criteria
You may qualify if:
- Male infertility unrelated to major testicular conditions
- Must have at least one altered seminal parameter.
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catalysis SLlead
Study Sites (1)
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, La Habana, 10400, Cuba
Related Publications (1)
de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
PMID: 35506389DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel Aguilar Charara, MD
"Ramón González Coro" Gynecologic and Obstetric Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 8, 2011
Record last verified: 2011-03