Ovarian Reserve Testing in Female Young Adult Cancer Survivors
- Registration Number
- NCT01421095
- Lead Sponsor
- University of California, San Diego
- Brief Summary
Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.
Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.
- Detailed Description
Same as brief summary
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 34
- Postmenarchal
- Cancer diagnosis
- Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy
- A minimum of 1 year since completion of gonoadotoxic therapy
- Intact uterus
- At least one ovary
- Estrogen receptor positive cancers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Basal Testing recombinant FSH -
- Primary Outcome Measures
Name Time Method Return of menses 3 months Self reported via bleeding calenders
- Secondary Outcome Measures
Name Time Method Blood levels of FSH 3 months Blood levels of AMH 3 months Blood levels of estradiol 3 months Blood levels of inhibin B 3 months
Trial Locations
- Locations (1)
UCSD Moores Cancer Center
🇺🇸San Diego, California, United States