An observational study in Infertility, Female, sponsored by KK Women's and Children's Hospital. Completed at 1 site in Singapore. Open to female participants aged 21 Years to 43 Years. Per ClinicalTrials.gov, last updated 2018-08-07.
Sponsored by KK Women's and Children's Hospital · Observational
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.
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's enrollment of 124 is below the median of 161 across 162 observational studies indexed under Infertility, Female.
Browse Infertility, Female studies →KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.
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Asian Normogonadotrophic Anovulatory Women
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Asian women with normal gonadotropin levels but do not ovulate.
Achievement of successful ovulation
Successful ovulation is defined as a mid-luteal phase serum progesterone level of \>20 nmol/L.
Time frame: Day 20-23 of menses cycle
Plan to share: Undecided
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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