Spermotrend in the Treatment of Male Infertility - Full Text View

Sponsor:	Catalysis SL
Information provided by:	Catalysis SL
ClinicalTrials.gov Identifier:	NCT00975117

Purpose

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.

Condition	Intervention	Phase
Male Infertility	Dietary Supplement: Placebo Dietary Supplement: Spermotrend	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Assessment of the Efficacy of Dietary Supplement Spermotrend in the Treatment of Male Infertility

Resource links provided by NLM:

Genetics Home Reference related topics: CATSPER1-related nonsyndromic male infertility sensorineural deafness and male infertility Y chromosome infertility

MedlinePlus related topics: Dietary Supplements Infertility Male Infertility

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:

Parameters of seminal analysis at weeks 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fertilization achievement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Presence of mild or severe adverse effects [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	86
Study Start Date:	September 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Dietary Supplement: Placebo One Placebo tablet (Orally administered) twice a day, for 12 weeks.
Experimental: Spermotrend	Dietary Supplement: Spermotrend One Spermotrend tablet (Orally administered) twice a day, for 12 weeks

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975117

Locations

Cuba
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana, Cuba, 10400

Sponsors and Collaborators

Catalysis SL

Investigators

Principal Investigator:

Miguel Aguilar Charara, MD

"Ramón González Coro" Gynecologic and Obstetric Hospital

More Information

No publications provided

Responsible Party:	Miguel Aguilar Charara, "Ramón González Coro" Gynecologic and Obstetric Hospital
ClinicalTrials.gov Identifier:	NCT00975117 History of Changes
Other Study ID Numbers:	CAT-0905-CU
Study First Received:	September 10, 2009
Last Updated:	March 6, 2011
Health Authority:	Cuba: Institutional Review Board

Keywords provided by Catalysis SL:

Dietary supplement
male infertility
spermatogenesis

Additional relevant MeSH terms:

Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012