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Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles? - NCT00804960-10021(Clinical Trial 258037)



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City:  New York
State:  
NY
Zip Code: 10021
Conditions: Infertility
Purpose: This research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.
Study summary: Specific Aim: 1. To determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an IVF-ET cycle, thereby reducing the cost. 2. To determine whether letrozole improves IVF-ET success compared to standard ovarian stimulation protocols. Null Hypothesis: Use of Letrozole for ovulation induction in IVF is not less expensive than the standard therapy by a clinically relevant amount. Alternative Hypothesis: Use of Letrozole for ovulation induction in IVF is better than the standard therapy by a clinically relevant amount. Protocol: Infertile women <40 years of age with age-appropriate ovarian reserve (as determined by day2/3 E2, FSH, and AMH) will be randomized between two protocols: one with letrozole and one with standard ovulation induction. In both groups, serum FSH will be measured each time a sample is obtained for estradiol. Sera will be frozen for further batch assay. Number of embryos to be transferred will be decided following the ASRM guidelines. The day of embryo transfer (D-3 vs D-5) will be based on the number and quality of embryos as per established clinical criteria. Power Considerations A review of 1473 cycles of patients less than 40 years old over the last 6 years (2002 - 2008) revealed average cost per cycle to be $3,152 +/- 1685(SD). For the purpose of this power analysis we consider a 20% decrease in medication cost to be clinically significant. Thus a decrease from $ 3152.83 to $ 2522.26 will be considered clinically significant (20% decrease). For an alpha of 0.05 and a power of 80% for a two tailed test 113 patients will need to complete each arm. Allowing for 10% drop-out we will attempt to randomize 125 patients to each arm of the study.
Criteria: Inclusion Criteria: 1. Normal Ovarian Function 2. Normal uterus Exclusion Criteria: 1. Age 40 and above 2. Diminished ovarian reserve (based on markers and/or previous poor response) 3. Previous oophorectomy
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Data Source: ClinicalTrials.gov
Date Processed: September 9, 2010
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