NCT01403688

Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin

Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: University of Kansas · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infertility
• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	RPFNA	1. Baseline RPFNA within 3 month prior to the initial COH cycle or within the first 10 days of the treatment cycle (delete this). 2. Repeat RPFNA if pregnancy is not achieved: 6 to 18 months following baseline assessment 3. Repeat RPFNA if pregnancy is achieved: approximately 12 months after discontinuation of breast feeding

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2011-07-27
• Last updated: 2014-09-17

Locations

1 site across 1 country: United States