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

Infertility Clinical Trial

— Cost-Less  

Official title:

Controlled Ovarian Stimulation With Letrozole Supplementation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00804960
• Other study ID #: CHR #5/17/08-2
• Status: Withdrawn
• Phase: Phase 4
• First received: December 5, 2008
• Last updated: June 24, 2015
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2015
• Source: Center for Human Reproduction
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Human Reproduction	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Center for Human Reproduction

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of Treatment		4 weeks	No
Secondary	Pregnancy and implantation rates		4 weeks	No
Secondary	Incidence of Ovarian Hyper stimulation Syndrome		4 weeks	Yes
Secondary	Multiple Birth Rate		10 months	Yes