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

NCT ID: NCT01403688

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-08-31

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.

Conditions

Infertility; Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Random Fine Needle Aspiration (RPFNA)

RPFNA

RPFNA

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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 adnexal pathology

6. Use of clomid or gonadotropin within 30days before the letrozole cycle

7. Any severe chronic disease of relevance for reproductive function

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Kim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

The University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

11357

Identifier Type: -

Identifier Source: org_study_id