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Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles? (Cost-Less)

This study has been withdrawn prior to enrollment.
(lack of recruitment at this site)
Sponsor:
Information provided by:
Center for Human Reproduction
ClinicalTrials.gov Identifier:
NCT00804960
First received: December 5, 2008
Last updated: September 14, 2010
Last verified: September 2010

December 5, 2008
September 14, 2010
September 2008
December 2009   (final data collection date for primary outcome measure)
Cost of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00804960 on ClinicalTrials.gov Archive Site
  • Pregnancy and implantation rates [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Incidence of Ovarian Hyper stimulation Syndrome [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Multiple Birth Rate [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?
Controlled Ovarian Stimulation With Letrozole Supplementation

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Drug: Letrozole
    1) Letrozole 5 mg starting on cycle day 2, which will be continued until the day of trigger. Recombinant FSH at doses 100-225 units, as determined by BMI, AFC, age, and ovarian reserve markers will be added on cycle day 4. The dose will be adjusted based on the response. An antagonist will be administered once the lead follicle reaches 14-mm in diameter or when estradiol level reaches 250 pg/mL. Oocyte maturation will be triggered by 20 iu of leuprolide acetate.
    Other Name: Femara
  • Drug: Std IVF Protocol
    2) Long protocol with luteal phase GnRHa suppression with gonadotropin dose at 200-450 IU. Oocyte maturation will be triggered by 250 micg of ovidrel.
    Other Name: Ovulation induction with Human Menopausal gonoadotropins
  • Experimental: Letrozole
    1) Letrozole/ Recombinant FSH
    Intervention: Drug: Letrozole
  • Active Comparator: Standard IVF
    luteal phase GnRHa suppression/gonadotropin
    Intervention: Drug: Std IVF Protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
250
April 2010
December 2009   (final data collection date for primary outcome measure)

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
Female
21 Years to 38 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00804960
CHR #5/17/08-2
No
Kutluk Oktay, MD, Center for Human Reproduction
Center for Human Reproduction
Not Provided
Study Director: David Barad, MD. MS CHR
Principal Investigator: Kutluk Oktay, MD CHR/ New York Medical College
Center for Human Reproduction
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP