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This study has been withdrawn prior to enrollment.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
  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.


Condition Intervention Phase
Infertility
Drug: Letrozole
Drug: Std IVF Protocol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Controlled Ovarian Stimulation With Letrozole Supplementation

Resource links provided by NLM:


Further study details as provided by Center for Human Reproduction:

Primary Outcome Measures:
  • Cost of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: September 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804960

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

No publications provided

Responsible Party: Kutluk Oktay, MD, Center for Human Reproduction
ClinicalTrials.gov Identifier: NCT00804960     History of Changes
Other Study ID Numbers: CHR #5/17/08-2
Study First Received: December 5, 2008
Last Updated: September 14, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014