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CompletedNCT01403688Updated Sep 17, 2014

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

An observational study in Infertility and Breast Cancer, sponsored by University of Kansas. Completed at 1 site in United States. Open to female participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by University of Kansas · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
9
Ages
21 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility
  • Breast Cancer

Keywords

  • fertility high risk, controlled ovarian stimulation, breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 9 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
9 participants (actual)

Groups and cohorts

  • Random Fine Needle Aspiration (RPFNA)

    RPFNA

    Procedure: RPFNA

Interventions

  • ProcedureRPFNA

    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

06

What researchers measure

Primary outcomes

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

    Time frame: up to 12 months

07

Study locations

1 site
  • The University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01403688
Lead sponsor
University of Kansas
Responsible party
Sponsor
First posted
Jul 27, 2011
Start date
Jun 2011
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Sep 17, 2014

Study contacts

Samuel Kim, MD
principal investigator · The University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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