We're sorry, but this trial is no longer enrolling volunteers.
Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy
on ovarian reserve and fertility in patients with chronic myeloid leukemia or
gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone
levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more
about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.
I. To collect preliminary information to help design a study to look at longitudinal changes
in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine
kinase inhibitors (TKI) therapy.
I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to
undergo in vitro fertilization (IVF) for fertility preservation.
Patients undergo transvaginal ultrasound for antral follicles analysis and collection of
serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and
Inclusion and Exclusion Criteria
- Diagnosed with chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), non metastatic cancer where TKI is the first line agent
- Premenopausal (has had menses at any time in the preceding 12 consecutive months)
- Has not undergone a hysterectomy or bilateral oophorectomy
- Willing to use non-hormonal (ie: barrier method or abstinence) as form of contraception during the one year of study
- Patients who have had chemotherapy or radiotherapy in the past
- Patients may not be receiving any other investigational agents
- Patients must not be pregnant or nursing
- Other medical conditions or treatments that affect hormonal levels (potentially confounding interpretation of results)
- Patients with ongoing hormonal contraception or unwilling or unable to discontinue will not eligible
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.