To Study The Influence Of Genomic Factors On Metabolism And Effects Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.
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|ClinicalTrials.gov Identifier: NCT02548039|
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : August 7, 2018
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||124 participants|
|Official Title:||To Study The Influence Of Pharmacogenomics Factors On Pharmacokinetics And Pharmacodynamics Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients.|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||May 2018|
Asian Normogonadotrophic Anovulatory Women
Asian women with normal gonadotropin levels but do not ovulate.
- Achievement of successful ovulation [ Time Frame: Day 20-23 of menses cycle ]Successful ovulation is defined as a mid-luteal phase serum progesterone level of >20 nmol/L.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548039
|KK Women's and Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Jerry Chan, MB BCh BaO (Hons) MA,FRCOG,PhD||KK Women's and Children's Hospital|