Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin
Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).
The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer|
- evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Random Fine Needle Aspiration (RPFNA)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01403688
|United States, Kansas|
|The University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Samuel Kim, MD||The University of Kansas Medical Center|