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CompletedNCT00975117Updated Mar 8, 2011

Spermotrend in the Treatment of Male Infertility

A Phase 3 interventional study of Placebo and Spermotrend in Male Infertility, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to male participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-03-08.

Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Male Infertility

Keywords

  • Dietary supplement
  • male infertility
  • spermatogenesis
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 86 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Catalysis SL is the lead sponsor of 52 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Male infertility unrelated to major testicular conditions
  • Must have at least one altered seminal parameter.
  • Signed informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
86 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo

  • Experimental
    Spermotrend

    Dietary Supplement: Spermotrend

Interventions

  • Dietary supplementPlacebo

    One Placebo tablet (Orally administered) twice a day, for 12 weeks.

  • Dietary supplementSpermotrend

    One Spermotrend tablet (Orally administered) twice a day, for 12 weeks

06

What researchers measure

Primary outcomes

  1. Parameters of seminal analysis at weeks 24

    Time frame: 24 weeks

Secondary outcomes

  1. Fertilization achievement

    Time frame: 24 weeks

  2. Presence of mild or severe adverse effects

    Time frame: 24 weeks

07

Study locations

1 site
  • "Ramón González Coro" Gynecologic and Obstetric Hospital
    Havana, 10400, Cuba
08

References and documents

Publications

  • 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. PubMed 35506389 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00975117
Lead sponsor
Catalysis SL
First posted
Sep 11, 2009
Start date
Sep 2009
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Mar 8, 2011

Study contacts

Miguel Aguilar Charara, MD
principal investigator · "Ramón González Coro" Gynecologic and Obstetric Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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