Trial intelligence / Profile preview

Fixed vs Titrated Letrozole for IVF in Breast Cancer

NCT01035099Phase 4

Key facts

Status: Completed
Start: Nov 2009
Primary completion: Jul 2019
Countries: 1
Sponsor: Weill Cornell Medicine
Modality: Orthosteric Ligands

Drugs: letrozole
Conditions: infertility

Overview

Phase 4, randomised, open-label trial of letrozole in infertility (2 arms), sponsored by Weill Cornell Medicine. Primary endpoints: Mature Oocyte Yield and Percent of Mature Oocyte Yield. Started Nov 2009; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Fixed dose Letrozole
Letrozole 5mg daily + Gonadotropins
Titrated dose Letrozole
Letrozole 0-7.5mg titrated + Gonadotropins

Who it enrols

Female breast cancer patients under 45 years old, prior to chemotherapy, desiring fertility preservation. Must have FSH < 25 and be medically cleared by oncologist.

Endpoints

Primary

Mature Oocyte Yield1 to 2 months
Percent of Mature Oocyte Yield1 to 2 months

Secondary

Participant Cycle Cancellation Rate1 to 2 months
Breast Cancer Recurrence Rate5 years
Peak Serum Estradiol Level1 to 2 months
Total Number of Oocytes1 to 2 months
Number of Fertilized Oocytes1 to 2 months
Number of Good Quality Embryos1 to 2 months

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