Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor
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.
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.
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
Exclusion Criteria:
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
