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Aromatase Inhibitor

Letrozole for Polycystic Ovary Syndrome (LEFT Trial)

Phase 4
Waitlist Available
Research Sponsored by CRG UZ Brussel
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 1 year
Awards & highlights

LEFT Trial Summary

To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.

Eligible Conditions
  • Polycystic Ovary Syndrome
  • Female Infertility
  • Ovulatory Dysfunction
  • In Vitro Fertilization

LEFT Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
early pregnancy loss
Secondary outcome measures
biochemical and clinical pregnancy rate
cancellation rate
endometrial thickness on the day of planning of FET
+6 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

LEFT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LetrozoleExperimental Treatment1 Intervention
Using letrozole for ovulation induction before planning the frozen embryo transfer
Group II: Hormonal Replacement TherapyActive Control1 Intervention
Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letrozole
FDA approved

Who is running the clinical trial?

University Hospital, GhentOTHER
714 Previous Clinical Trials
143,529 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
12 Patients Enrolled for Polycystic Ovary Syndrome
CRG UZ BrusselLead Sponsor
11 Previous Clinical Trials
3,124 Total Patients Enrolled
~0 spots leftby Jun 2025