Male InfertilityPhase 3NCT00975117
Spermotrend in the Treatment of Male Infertility
A Phase 3 study testing Spermotrend in people with Male Infertility, run by Catalysis SL at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Spermotrend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteCuba
- Study dates
- Sep 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male infertility unrelated to major testicular conditions
- Must have at least one altered seminal parameter.
- Signed informed consent
Who cannot join
- 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.
Show all 9Show fewer
- Use of hormones prescribed by an andrologist within 6 months
- Positive serology/HIV
- Leukocytospermia
Trial locations and contacts
1 site in 1 country.
Cuba1 site
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, La Habana, 10400
About this study
Official title: Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
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.
- Conditions
- Male Infertility
- Being tested
- Placebo, Spermotrend
- Keywords
- Dietary supplement, male infertility, spermatogenesis
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
One Placebo tablet (Orally administered) twice a day, for 12 weeks.
SpermotrendDietary supplement
One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Spermotrend | Experimental | Not described Receives: Dietary Supplement: Spermotrend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of seminal analysis at weeks 24
Measured: 24 weeks
Secondary outcomes (2)
Fertilization achievement
Measured: 24 weeks
Presence of mild or severe adverse effects
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Miguel Aguilar Charara, MD, Principal investigator, "Ramón González Coro" Gynecologic and Obstetric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975117
- Sponsor's protocol ID
- CAT-0905-CU
- Status last verified
- Mar 2011
- First submitted
- 10 Sep 2009
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility
- ClinicalTrials.gov ID
- NCT00975117
- Acronym / sponsor ID
- CAT-0905-CU
- Conditions
- Male Infertility
- Keywords
- Dietary supplement, male infertility, spermatogenesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Spermotrend | Experimental | Dietary Supplement: Spermotrend |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male infertility unrelated to major testicular conditions
- Must have at least one altered seminal parameter.
- Signed informed consent
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOne Placebo tablet (Orally administered) twice a day, for 12 weeks. | Dietary supplement | Placebo |
| SpermotrendOne Spermotrend tablet (Orally administered) twice a day, for 12 weeks | Dietary supplement | Spermotrend |
Primary outcome
Parameters of seminal analysis at weeks 24
Time frame: 24 weeks
2 secondary outcomes
Fertilization achievement
Time frame: 24 weeks
Presence of mild or severe adverse effects
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
- Derived from this study: PubMed 35506389de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Aguilar Charara, MD principal investigator
"Ramón González Coro" Gynecologic and Obstetric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Spermotrend in people with Male Infertility, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of seminal analysis at weeks 24 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.