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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403688
• Other study ID #: 11357
• Status: Completed
• Phase: N/A
• First received: July 14, 2011
• Last updated: September 16, 2014
• Start date: June 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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 adnexal pathology

6. Use of clomid or gonadotropin within 30days before the letrozole cycle

7. Any severe chronic disease of relevance for reproductive function

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Infertility
• Ovarian Hyperstimulation Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	The University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers		up to 12 months	No