Male Infertility Clinical Trial
Official title:
Choline Dehydrogenase and Sperm Function: Effects of Betaine
The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.
Unidentified genetic aberrations such as single nucleotide polymorphisms (SNPs) may be the
underlying cause of many cases of idiopathic infertility in men. Choline dehydrogenase
(encoded by CHDH) converts choline to betaine in the mitochondria. 5-9% of men have 2
alleles for a functional SNP in CHDH (rs12676), and they have low sperm adenosine
triphosphate (ATP) concentrations with impaired sperm motility (asthenospermia) that should
decrease fertility. Male mice in which CHDH is deleted also have very low sperm ATP,
asthenospermia and are infertile. Supplementation of these mice with dietary betaine
increases sperm motility and ATP concentrations.
This purpose of this study is to conduct a phase I study of betaine treatment in men with 2
minor alleles for CHDH rs12676 to determine whether betaine supplementation is safe and to
obtain preliminary data on the effects of betaine on sperm mitochondrial ATP concentrations
and sperm motility in these men.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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