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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
Samuel Kim, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01403688
First received: July 14, 2011
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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
Infertility
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:

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 ]

Estimated Enrollment: 12
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Random Fine Needle Aspiration (RPFNA)
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

  Eligibility

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Samuel Kim, MD 913-588-2229 skim2@kumc.edu

Locations
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Samuel Kim, MD    913-588-2229    skim2@kumc.edu   
Principal Investigator: Samuel Kim, MD         
Sponsors and Collaborators
Samuel Kim, MD
Investigators
Principal Investigator: Samuel Kim, MD The University of Kansas Medical Center
  More Information

No publications provided

Responsible Party: Samuel Kim, MD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01403688     History of Changes
Other Study ID Numbers: 11357
Study First Received: July 14, 2011
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Infertility
Ovarian Hyperstimulation Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014