Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
DescriptionPRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo in vitro fertilization (IVF) for fertility preservation. OUTLINE: 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 48 weeks.
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.