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

Completed

• Conditions: Breast Cancer; Infertility
• Interventions: Procedure: RPFNA

• Registration Number: NCT01403688
• Lead Sponsor: University of Kansas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-27
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Random Fine Needle Aspiration (RPFNA)	RPFNA	RPFNA

Primary Outcome Measures

Name	Time	Method
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers	up to 12 months

Trial Locations

Locations (1)

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States