Spermotrend in the Treatment of Male Infertility
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Male Infertility
Intervention
Placebo, Spermotrend
Location
"Ramón González Coro" Gynecologic and Obstetric Hospital
Havana
Cuba
10400
Status
Recruiting
Source
Catalysis SL
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00975117
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Infertility, Male
The inability of the male to effect FERTILIZATION of an OVUM after a specified period of unprotected intercourse. Male sterility is permanent infertility.
Sperm Injections, Intracytoplasmic
An assisted fertilization technique consisting of the microinjection of a single viable sperm into an extracted ovum. It is used principally to overcome low sperm count, low sperm motility, inability of sperm to penetrate the egg, or other conditions related to male infertility (INFERTILITY, MALE).
Klinefelter Syndrome
A form of male HYPOGONADISM, characterized by the presence of an extra X CHROMOSOME, small TESTES, seminiferous tubule dysgenesis, elevated levels of GONADOTROPINS, low serum TESTOSTERONE, underdeveloped secondary sex characteristics, and male infertility (INFERTILITY, MALE). Patients tend to have long legs and a slim, tall stature. GYNECOMASTIA is present in many of the patients. The classic form has the karyotype 47,XXY. Several karyotype variants include 48,XXYY; 48,XXXY; 49,XXXXY, and mosaic patterns ( 46,XY/47,XXY; 47,XXY/48,XXXY, etc.).
Andrology
A scientific or medical discipline concerning the study of male reproductive biology, diseases of the male genital organs, and male infertility. Major areas of interest include ENDOCRINOLOGY; SPERMATOGENESIS; semen analysis; FERTILIZATION; CONTRACEPTION; and CRYOPRESERVATION.
Infertility
Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
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