Clinical trial NCT00804960: Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?
Official title: Controlled Ovarian Stimulation With Letrozole Supplementation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Keywords: Cost of Infertility Treatment
Ovulation Induction
Letrozole
In Vitro Fertilization
Lead sponsor: Center for Human Reproduction
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Cost of Treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Pregnancy and implantation rates
timeFrame: 4 weeks
measure: Incidence of Ovarian Hyper stimulation Syndrome
timeFrame: 4 weeks
measure: Multiple Birth Rate
timeFrame: 10 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for Human Reproduction
state: New York
Study officials:
affiliation: CHR
name: David Barad, MD. MS
role: STUDY_DIRECTOR
affiliation: CHR/ New York Medical College
name: Kutluk Oktay, MD
role: PRINCIPAL_INVESTIGATOR
References: