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Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer


N/A
21 Years
45 Years
Open (Enrolling)
Female
Infertility, Breast Cancer

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Trial Information

Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers

Outcome Time Frame:

up to 12 months

Safety Issue:

No

Principal Investigator

Samuel Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Kansas Medical Center

Authority:

United States: Institutional Review Board

Study ID:

11357

NCT ID:

NCT01403688

Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Infertility
  • Breast Cancer
  • fertility high risk, controlled ovarian stimulation, breast cancer
  • Breast Neoplasms
  • Infertility
  • Ovarian Hyperstimulation Syndrome

Name

Location

The University of Kansas Medical CenterKansas City, Kansas  66160