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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02548039 |
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Date of registration:
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08/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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To Study The Influence Of Pharmacogenomics Factors On Pharmacokinetics And Pharmacodynamics Of Clomiphene In Asian Normogonadotrophic Anovulatory Patients. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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124 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02548039 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Jerry Chan, MB BCh BaO (Hons) MA,FRCOG,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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KK Women's and Children's Hospital |
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Key inclusion & exclusion criteria
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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)
Age minimum:
21 Years
Age maximum:
43 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility, Female
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Primary Outcome(s)
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Achievement of successful ovulation
[Time Frame: Day 20-23 of menses cycle]
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Secondary ID(s)
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2014/RM/001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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