Assessing Fertility Potential in Female Cancer Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01143844|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2010
Last Update Posted : July 16, 2019
Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy.
At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.
|Condition or disease|
|Effects of Chemotherapy|
Up to 400 females will participate in this study in one of three cohorts:
- 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy
- 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy
- 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy
|Study Type :||Observational|
|Actual Enrollment :||391 participants|
|Official Title:||Assessing Fertility Potential in Female Cancer Survivors|
|Actual Study Start Date :||March 2006|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Exposed females, ages 11-40
Unexposed females, ages 40-50
Unexposed females, ages 11-35
- Reproductive hormones [ Time Frame: Annually for 3-5 years ]Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).
- Antral Follicle Counts [ Time Frame: Annually for 3-5 years ]All ovarian follicles and cysts will be measured by transvaginal or transabdominal ultrasound. Follicles will be measured in millimeters and grouped according to size: 2-5 mm, 6-9 mm, and >10 mm in diameter.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143844
|United States, Pennsylvania|
|Penn Reproductive Research Unit, 3701 Market Street, Suite 810|
|Philadelphia, Pennsylvania, United States, 19104|
|Penn Medicine at Radnor, 250 King of Prussia Road|
|Radnor, Pennsylvania, United States, 19087|
|Principal Investigator:||Clarisa R Gracia, MD, MSCE||University of Pennsylvania|