Infertility, Female Clinical Trial
Official title:
To Study The Influence Of Pharmacogenomics Factors On Pharmacokinetics And Pharmacodynamics Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.
The purpose of this study is to match the genetic component and clinical attributes of
anovulatory patients with response to clomiphene treatment.
By improving our understanding on patient-specific clomiphene response will allow
optimization of treatment, reduction of side-effects and shorten the time-to-pregnancy.
Anovulation is the commonest cause for infertility, with clomiphene being the standard
treatment. Pharmacogenetic causes of variability in the pharmacokinetics and pharmacodynamics
of clomiphene is not well characterized in anovulatory Asian women. Although recent findings
suggest that the pharmacokinetics and pharmacodynamics of clomiphene may be influenced by
several polygenic pathways involving genes regulating its metabolism (CYP3A4, CYP3A5, CYP2B6,
CYP2C8, CYP2C19, CYP2D6), thus contributing significantly to the wide variability in
dose-response relationships observed in clinical practice. There has not been objective
evidence thus far from an unbiased genome-wide perspective. It is likely that polymorphisms
at the CYP cluster of genes encoding for their respective cytochrome proteins may not explain
all of the variability with regards to clomiphene's dose-response relationship.
The investigators hypothesize that the pharmacokinetics and pharmacodynamics of clomiphene is
under strong control by genetic loci and that these genetic variants could also strongly
determine the therapeutic outcome in Asian normogonadotrophic anovulatory patients. The
contribution by candidate genes mentioned above will also be clarified in a definitive manner
by this study.
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