NCT02548039

To Study The Influence Of Genomic Factors On Metabolism And Effects Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.

To Study The Influence Of Pharmacogenomics Factors On Pharmacokinetics And Pharmacodynamics Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 124 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infertility, Female

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-03-01
• Completion: 2018-05-01
• First posted: 2015-09-14
• Last updated: 2018-08-07

Locations

1 site across 1 country: Singapore