Spermotrend in the Treatment of Male Infertility

Phase 3

Completed

• Conditions: Male Infertility
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Spermotrend

• Registration Number: NCT00975117
• Lead Sponsor: Catalysis SL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-06
• Last Update Posted: 2011-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Spermotrend	Spermotrend	-

Primary Outcome Measures

Name	Time	Method
Parameters of seminal analysis at weeks 24	24 weeks

Secondary Outcome Measures

Name	Time	Method
Fertilization achievement	24 weeks
Presence of mild or severe adverse effects	24 weeks

Trial Locations

Locations (1)

"Ramón González Coro" Gynecologic and Obstetric Hospital; 🇨🇺 Havana, Cuba