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

NCT00804960 | Withdrawn Phase 4

• 1 other identifier: CHR #5/17/08-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Cost of Infertility Treatment; Ovulation Induction; Letrozole; In Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Cost of Treatment

  4 weeks

Secondary Outcomes (3)

• Pregnancy and implantation rates

  4 weeks

• Incidence of Ovarian Hyper stimulation Syndrome

  4 weeks

• Multiple Birth Rate

  10 months

Study Arms (2)

Letrozole

EXPERIMENTAL

1\) Letrozole/ Recombinant FSH

Drug: Letrozole

Standard IVF

ACTIVE COMPARATOR

luteal phase GnRHa suppression/gonadotropin

Drug: Std IVF Protocol

Interventions

Letrozole DRUG

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.

Also known as: Femara

Letrozole

Std IVF Protocol DRUG

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.

Also known as: Ovulation induction with Human Menopausal gonoadotropins

Standard IVF

Eligibility Criteria

• Age: 21 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal Ovarian Function
• Normal uterus

You may not qualify if:

• Age 40 and above
• Diminished ovarian reserve (based on markers and/or previous poor response)
• Previous oophorectomy

Sponsors & Collaborators

• Center for Human Reproduction: lead

Study Sites (1)

Center for Human Reproduction

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Letrozole; Ovulation Induction

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• David Barad, MD. MS

  CHR

  STUDY DIRECTOR

• Kutluk Oktay, MD

  CHR/ New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 5, 2008
• First Posted: December 9, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

US (1)