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Spermotrend in the Treatment of Male Infertility

Primary Purpose

Male Infertility

Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Placebo
Spermotrend
Sponsored by
Catalysis SL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring Dietary supplement, male infertility, spermatogenesis

Eligibility Criteria

19 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • "Ramón González Coro" Gynecologic and Obstetric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Spermotrend

Arm Description

Outcomes

Primary Outcome Measures

Parameters of seminal analysis at weeks 24

Secondary Outcome Measures

Fertilization achievement
Presence of mild or severe adverse effects

Full Information

First Posted
September 10, 2009
Last Updated
March 6, 2011
Sponsor
Catalysis SL
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1. Study Identification

Unique Protocol Identification Number
NCT00975117
Brief Title
Spermotrend in the Treatment of Male Infertility
Official Title
Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catalysis SL

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Dietary supplement, male infertility, spermatogenesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Spermotrend
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One Placebo tablet (Orally administered) twice a day, for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Spermotrend
Intervention Description
One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
Primary Outcome Measure Information:
Title
Parameters of seminal analysis at weeks 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Fertilization achievement
Time Frame
24 weeks
Title
Presence of mild or severe adverse effects
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Aguilar Charara, MD
Organizational Affiliation
"Ramón González Coro" Gynecologic and Obstetric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Ramón González Coro" Gynecologic and Obstetric Hospital
City
Havana
ZIP/Postal Code
10400
Country
Cuba

12. IPD Sharing Statement

Citations:
PubMed Identifier
35506389
Citation
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.
Results Reference
derived

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Spermotrend in the Treatment of Male Infertility

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