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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
Sponsor:
Collaborator:
National Cancer Centre, Singapore
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Brief 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.


Condition or disease
Infertility, Female

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.

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Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Clomifene

Group/Cohort
Asian Normogonadotrophic Anovulatory Women
Asian women with normal gonadotropin levels but do not ovulate.



Primary Outcome Measures :
  1. 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
Plasma, serum and Genomic DNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asian Normogonadotrophic Anovulatory Women
Criteria

Inclusion Criteria:

  • Women of reproductive age with ovulatory dysfunction desiring pregnancy,
  • Willing to discontinue any form of herbal or traditional chinese medicines for at least three weeks before starting Clomiphene
  • Ability to provide written and informed consent taken from participating patients, and
  • Willingness to cooperate with study instructions

Exclusion Criteria:

  • Pregnant at the time of recruitment,
  • Ovarian cysts more than 5cm,
  • Abnormal menorrhagia at the time of study recruitment,
  • Abnormal liver function or active liver disease,
  • Presence of neoplastic lesions of any type,
  • Primary pituitary or ovarian failure (Type I and III World Health Organisation [WHO] Infertility)
  • Patients with previous treatment with ovulation inducing agents such as follicle stimulating hormone (FSH) and luteinising hormone releasing hormone-analogues (LHRH-analogues);
  • Infertility due to other endocrine abnormalities such as hyperprolactinaemia, hypo/hyperthyroidism, premature ovarian failure, diabetes or male factor
  • Allergy to clomiphene.
  • Fallopian tubal pathology (hydrosalpinges, previous salpingectomies)
  • Patients on any drugs with potential to interact with CYP2D6 such as the selective serotonin receptor uptake inhibitors (ex. Venlafaxine, paroxitene, fluoxetine)

Information from the National Library of Medicine

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


Locations
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Singapore
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Jerry Chan, MB BCh BaO (Hons) MA,FRCOG,PhD KK Women's and Children's Hospital
Publications:
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02548039    
Other Study ID Numbers: 2014/RM/001
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by KK Women's and Children's Hospital:
Anovulatory
Clomiphene
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Anovulation
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases