Dosage Optimization for Letrozole Treatment
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dosage Optimization for Letrozole Treatment in Clomiphene Resistant Patients With Polycystic Ovary Syndrome: A Prospective Interventional Study|
- normal follicular size [ Time Frame: two years ] [ Designated as safety issue: Yes ]
- clinical and current pregnancy rates [ Time Frame: two years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
In this prospective intervention, the investigators studied Abolfazle outpatients who were referred to us by Bushehr University of Medical Sciences in Iran between January 1, 2008 and December 30, 2010. The study was approved by the institutional Ethics Committee of Bushehr University of Medical Sciences and all patients were required to provide written informed consent before the study commenced.There were 3 steps in which the investigators prescribed letrozole (Femara,Novartis,Quebec,Canada). In all cases, daily administration began on the 3rd day of the menstrual cycle through to the 7th day (totaling 5 days). In the first step the investigators prescribed letrozole at a dose of 2.5 mg (one tablet) for one or two cycles according to the patient's response. Normal follicular size and endometrial thickness were considered 18-24 mm and 6 mm or more respectively.1 If the follicle was deemed not acceptable, the dose of letrozole was increased at the next cycle.
At the second and third steps the investigators prescribed letrozole at a dose of 5 mg daily and 7.5 mg/day,respectively and according to patient's response, repeat the same dose.
In the current study the investigators tested the hypothesis that prescribing letrozole as an ovulation induction agent in infertile women would increase pregnancy rate, ovulation and follicle number (at the normal size range of 18-24 mm), endometrial thickness (to normal thickness of 6 mm) and not have considerable side effects in the patients. The primary outcome measure was normal follicular size and the secondary outcome measure were the clinical and current pregnancy rates. Clinical pregnancy was considered as the presence of a gestational sac with fetal heart activity. Letrozole tablets were prescribed by an experienced nurse who throughly explained the method of use to the patients. Sonography was done by an experienced radiologist.
The nurse prescribed letrozole to the patients and the university hospital laboratory's technician did not know past medical history of clomiphene resistance of the patients. The radiologist did not have any knowledge about the drugs prescribed to the patients. Side effects and complications of Letrozole were detailed to all patients by an obstetrician. Statistical analysis was performed by the Statistical Package for Social Science version 11.5 for windows (SPSS Inc., Chicago. IL). The data was analyzed by student's t-test and chi-squared test for linear trend and comparing proportions. A P-value of <0.05 was considered to be statistically significant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315912
|Iran, Islamic Republic of|
|Bushehr university of medical science|
|Bushehr, Iran, Islamic Republic of, 0098|
|Principal Investigator:||Elham Rahmani, Dr||Bushehr University of Medical Science|