NCT00402935

Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

Effects of Cytotoxic Chemotherapy on Ovarian Structure and Function

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 14 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment. PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.

Detailed description

OBJECTIVES: * Determine the incidence and timing of ovarian dysfunction/damage in younger premenopausal women undergoing cytotoxic chemotherapy for cancer. * Determine the feasibility of a prospective, randomized study to assess if gonadotropin analogues can protect the ovary from the cytotoxic effects of chemotherapy. * Determine the number of patients required for adequate power to test the hypothesis. OUTLINE: This is a pilot, prospective study. Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications. PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

Conditions

• Leukemia
• Long-term Effects Secondary to Cancer Therapy in Adults
• Long-term Effects Secondary to Cancer Therapy in Children
• Lymphoma
• Sexual Dysfunction and Infertility
• Sexuality and Reproductive Issues
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels.
PROCEDURE	fertility assessment and management	Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.
PROCEDURE	management of therapy complications	Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.
PROCEDURE	ultrasound imaging	Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles.

Timeline

• Start date: 2004-02-01
• Completion: 2007-05-01
• First posted: 2006-11-23
• Last updated: 2012-03-20

Locations

1 site across 1 country: United States