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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Infertility
• Intervention / Treatment: Procedure: RPFNA

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Infertility Patients undergoing COH treatment and at high risk for breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Random Fine Needle Aspiration (RPFNA); RPFNA	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers	up to 12 months

Collaborators and Investigators

• Sponsor: University of Kansas
• Investigators: Principal Investigator: Samuel Kim, MD, The University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Estimate): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 16, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: fertility high risk, controlled ovarian stimulation, breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Infertility
• Other Study ID Numbers: 11357 (DAIDS ES)