View Clinical Trial (Medical Research Study)
Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer
| City: |
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Kansas City |
| State: |
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Kansas |
| Zip Code: |
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66160 |
| Conditions: |
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Infertility - Breast Cancer |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion criteria:
1. Women must be at increased risk for breast cancer based on any of the following
criteria :
- Age 30 or older with no prior live birth.
- Mutations associated with hereditary cancer ( BRCA1 or 2, P53, PTEN)
- Family history of breast cancer including one first degree or multiple second
degree relatives
- History of chest radiation before age 30
- Multiple prior breast biopsies
- Precancerous conditions (DCIS, LCIS, AH)
- Prior history of breast or ovarian cancer
- Estimated mammographic breast density > 50%
2. Must be undergoing infertility treatment at the University of Kansas with Controlled
Ovarian Hyper-stimulation ( COH)
3. Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12
IU/L, Day 3 E2 less than 80 pg/ml
Exclusion criteria:
1. Women under 21 or over 45 years old
2. Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
3. Women who do not meet risk criteria above
4. History of hypersensitivity to letrozole or gonadotropin
5. Uterine and adenexal pathology
6. Use of clomid or gonadotropin within 30days before the letrozole cycle
7. Any severe chronic disease of relevance for reproductive function
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| NCT ID: |
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NCT01403688 |
| Primary Contact: |
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Principal Investigator
Samuel Kim, MD
The University of Kansas Medical Center
Samuel Kim, MD
Phone: 913-588-2229
Email: skim2@kumc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Kansas City, Kansas 66160
United States
Samuel Kim, MD
Phone: 913-588-2229
Email: skim2@kumc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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