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

NCT01403688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2014-09-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Kansas

    lead OTHER

Principal Investigators

  • Samuel Kim, MD · University of Kansas Medical Center

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01403688 on ClinicalTrials.gov