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Aromatase Inhibitor

Letrozole for Infertility

Phase 4
Waitlist Available
Led By Glenn Schattman, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is comparing two different ways to administer letrozole to see which is more effective in blocking estrogen production during ovarian stimulation.

Eligible Conditions
  • Infertility
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mature Oocyte Yield
Percent of Mature Oocyte Yield
Secondary outcome measures
AF Count
AMH ng/ml (Cycle Day 2)
Breast Cancer Recurrence Rate
+11 more

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538
10%
Fracture
8%
Acne
5%
Scoliosis
3%
Hair loss
3%
Sacroiliitis
3%
Neuro event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anastrozole
Letrozole

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Titrated dose LetrozoleExperimental Treatment1 Intervention
Patients who are randomized to the titrated dose of Letrozole, will start gonadotropins in the evening of day #2 of their menstrual cycle with injectable follicle stimulating hormone (FSH) and human menopausal gonadotropin (HMG). Oral Letrozole will be added to the stimulation in the following titrated regimen.
Group II: Fixed dose LetrozoleActive Control1 Intervention
Patients who are randomized to fixed dose Letrozole will start Letrozole 5mg daily (orally) on the second day of their menstrual cycle and then gonadotropins on the fourth day of their menstrual cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
2002
Completed Phase 4
~3240

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,604 Total Patients Enrolled
24 Trials studying Infertility
8,592 Patients Enrolled for Infertility
Glenn Schattman, MDPrincipal InvestigatorWeill Cornell Medical Cornell
4 Previous Clinical Trials
331 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Missouri
North Carolina
Other
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medical College
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
2009. "RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01035099.
~3 spots leftby Apr 2025
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