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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01403688
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : September 17, 2014
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )

Brief 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.

Condition or disease Intervention/treatment
Infertility Breast Cancer Procedure: RPFNA

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Study Type : Observational
Actual Enrollment : 9 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers [ Time Frame: up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01403688

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United States, Kansas
The University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
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Principal Investigator: Samuel Kim, MD The University of Kansas Medical Center
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Responsible Party: University of Kansas Identifier: NCT01403688    
Other Study ID Numbers: 11357
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by University of Kansas Medical Center ( University of Kansas ):
fertility high risk, controlled ovarian stimulation, breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female