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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804960
Recruitment Status : Withdrawn (lack of recruitment at this site)
First Posted : December 9, 2008
Last Update Posted : June 25, 2015
Information provided by:
Center for Human Reproduction

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Letrozole Drug: Std IVF Protocol Phase 4

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.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Ovarian Stimulation With Letrozole Supplementation
Study Start Date : September 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Letrozole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Letrozole
1) Letrozole/ Recombinant FSH
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
Active Comparator: Standard IVF
luteal phase GnRHa suppression/gonadotropin
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

Primary Outcome Measures :
  1. Cost of Treatment [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Pregnancy and implantation rates [ Time Frame: 4 weeks ]
  2. Incidence of Ovarian Hyper stimulation Syndrome [ Time Frame: 4 weeks ]
  3. Multiple Birth Rate [ Time Frame: 10 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00804960

United States, New York
Center for Human Reproduction
New York, New York, United States, 10021
Sponsors and Collaborators
Center for Human Reproduction
Study Director: David Barad, MD. MS CHR
Principal Investigator: Kutluk Oktay, MD CHR/ New York Medical College

Responsible Party: Kutluk Oktay, MD, Center for Human Reproduction Identifier: NCT00804960     History of Changes
Other Study ID Numbers: CHR #5/17/08-2
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Center for Human Reproduction:
Cost of Infertility Treatment
Ovulation Induction
In Vitro Fertilization

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs