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

This study has been completed.
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
First received: July 14, 2011
Last updated: September 16, 2014
Last verified: September 2014

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.

Condition Intervention
Breast Cancer
Procedure: RPFNA

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: June 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Random Fine Needle Aspiration (RPFNA)
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


Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Infertility Patients undergoing COH treatment and at high risk for breast cancer

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01403688

United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Principal Investigator: Samuel Kim, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01403688     History of Changes
Other Study ID Numbers: 11357 
Study First Received: July 14, 2011
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
fertility high risk, controlled ovarian stimulation, breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Hyperstimulation Syndrome
Adnexal Diseases
Breast Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 04, 2016