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Main
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Note: This record shows only the 20 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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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2008/015 |
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Date of registration:
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18/07/2008 |
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Primary sponsor: |
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Public title:
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The efficacy of letrozole compared to clomifene in
induction and augmentation of ovulation in infertility
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Scientific title:
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A study on anti-eostrogen clomifene citrate and aromatase inhibitor letrozole in induction of ovulation, in WHO group II anovulatory subjects, and in augmentation of ovulation in ovulatory infertility |
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Date of first enrolment:
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15/8/2008 |
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Target sample size:
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Phase 1: 100, Phase 2 : 25 in each arm |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={0731F326-F0AC-4B04-89C1-9D8792AB9DE5} |
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Study type:
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Interventional |
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Study design:
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Phase one would be an interventional study Phase two of the study would be a randomised clinical trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr. Thilina S Palihawadana
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Address:
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Faculty of Medicine, No 6, Thalagolla Road, Ragama
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Telephone:
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0714 089474 |
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Email:
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palihawadana_t@sltnet.lk |
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Affiliation:
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Lecturer, Dept of Obs and Gyn |
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Name:
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Dr. Thilina S Palihawadana
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Address:
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Faculty of Medicine, No 6, Thalagolla Road, Ragama
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Telephone:
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0714089474 |
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Email:
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palihawadana_t@sltnet.lk |
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Affiliation:
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Lecturer, Dept of Obs and Gyn |
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Key inclusion & exclusion criteria
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Inclusion criteria: Phase I: participants with WHO group II anovulatory infertility
Phase II: Participants with unexplained infertility
Exclusion criteria: 1. Previous ovarian surgery
2. Endocrinopathies (other than PCOS) giving rise to anovulation
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Anovulatory and unexplained infertility
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Intervention(s)
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In phase one: ovulation induction with clomifene citrate followed by letrozole in patients with anovulatory infertility In phase two: Subjects with unexplained infertility would undergo augmentation of ovulation with either clomifene citrate or letrozole randomly followed by other agent after a three month drug free interval
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Primary Outcome(s)
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Phase 1: Ovulation rate, endometrial characteristics
Phase 2: Monofolicle development rate, endometrial characteristics
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Secondary Outcome(s)
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Follicular phase and luteal phase endocrinological changes
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Source(s) of Monetary Support
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Self funded
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