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

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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Key information

Conditions

Infertility Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases

Age range

21 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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%
Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
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

Women under 21 or over 45 years old
Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
Women who do not meet risk criteria above
History of hypersensitivity to letrozole or gonadotropin
Uterine and adnexal pathology
Use of clomid or gonadotropin within 30days before the letrozole cycle
Any severe chronic disease of relevance for reproductive function

Treatment and study plan

RPFNA

Procedure

Baseline RPFNA within 3 month prior to the initial COH cycle or within the first 10 days of the treatment cycle (delete this).
Repeat RPFNA if pregnancy is not achieved: 6 to 18 months following baseline assessment
Repeat RPFNA if pregnancy is achieved: approximately 12 months after discontinuation of breast feeding

Primary outcomes

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

Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 27, 2011
Registry last updated: Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed