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Aromatase Inhibitor

Letrozole for Female Infertility (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 up to 5 years
Awards & highlights
No Placebo-Only Group
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal 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
  • Female Infertility
  • Polycystic Ovary Syndrome
  • Ovulatory Dysfunction
  • In Vitro Fertilization

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
735 Previous Clinical Trials
147,516 Total Patients Enrolled
CRG UZ BrusselLead Sponsor
11 Previous Clinical Trials
2,964 Total Patients Enrolled
~0 spots leftby Nov 2025