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

July 14, 2011
October 21, 2013
June 2011
June 2015   (final data collection date for primary outcome measure)
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
We will assess the return of ovarian function after transplantation by measuring FSH, LH, E2 P4 levels. [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
Also achieving pregnancy after ovarian transplantation is another outcome measure.
Complete list of historical versions of study NCT01403688 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

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

  • Infertility
  • Breast Cancer
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
Random Fine Needle Aspiration (RPFNA)
RPFNA
Intervention: Procedure: RPFNA
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Female
21 Years to 45 Years
Yes
Contact: Samuel Kim, MD 913-588-2229 skim2@kumc.edu
United States
 
NCT01403688
11357
No
Samuel Kim, MD, University of Kansas Medical Center Research Institute
Samuel Kim, MD
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Principal Investigator: Samuel Kim, MD The University of Kansas Medical Center
University of Kansas
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP