Spermotrend in the Treatment of Male Infertility

Male Infertility Clinical Trial

Official title:

Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975117
• Other study ID #: CAT-0905-CU
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2009
• Last updated: March 6, 2011
• Start date: September 2009
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical 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. The estimated number of males with infertility to be recruited and randomized for the study is 86.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Dietary Supplement:
• Placebo
One Placebo tablet (Orally administered) twice a day, for 12 weeks.
• Spermotrend
One Spermotrend tablet (Orally administered) twice a day, for 12 weeks

Locations

Country	Name	City	State
Cuba	"Ramón González Coro" Gynecologic and Obstetric Hospital	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of seminal analysis at weeks 24		24 weeks	No
Secondary	Fertilization achievement		24 weeks	No
Secondary	Presence of mild or severe adverse effects		24 weeks	Yes