Assessing Fertility Potential in Female Cancer Survivors
2 other identifiers
observational
391
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2006
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedApril 13, 2021
April 1, 2021
14.1 years
June 11, 2010
April 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reproductive hormones
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).
Annually for 3-5 years
Secondary Outcomes (1)
Antral Follicle Counts
Annually for 3-5 years
Study Arms (3)
Exposed females, ages 11-40
* Prior exposure to alkylating agent chemotherapy and/or radiation therapy * At least 1 year from completion of chemotherapy and/or radiation therapy * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition (other than cancer) known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).
Unexposed females, ages 40-50
* Never exposed to chemotherapy or radiation therapy * Regular menstrual cycle (every 21-35 days) * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).
Unexposed females, ages 11-35
* Never exposed to chemotherapy or radiation therapy * Regular menstrual cycle (every 21-35 days) * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).
Eligibility Criteria
Subjects with a history of cancer, or other conditions treated by chemotherapy, will be identified through local survivorship programs or self-referral. In addition, two groups of regularly menstruating unexposed subjects will be recruited through local advertising: a group of similar-age subjects and another group in the late reproductive years. Exposed and unexposed controls will be frequency matched with respect to age (within 2 years) at enrollment. In addition,subjects will be balanced with respect to self reported race/ethnicity. Enrollment is purposefully targeted and stratified for this study to reflect the population in the pediatric and adult oncology practices.
You may qualify if:
- Previous treatment with chemotherapy and/or radiation therapy for either cancer or another illness.
- Age between 11-35 years.
- Post-menarchal.
- Presence of a uterus and at least one ovary.
- Ability and willingness to comply with study protocol.
- Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Healthy females who have never been treated for cancer.
- Age between 11-35 and 40-50 years.
- Post-menarchal with regular cyclic menses (every 21-35 days)
- Presence of a uterus and at least 1 ovary.
- Ability and willingness to comply with study protocol.
- Have given written informed concent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
You may not qualify if:
- Current pregnancy.
- Use of hormonal contraception or use of hormone replacement therapy within the previous 4 weeks.
- Lactation within the previous 3 months.
- Chronic illness that would limit ability of participant to comply with study protocol.
- Any known medical condition, other than cancer, which in the judgement of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).
- For controls, a history of infertility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Children's Hospital of Philadelphiacollaborator
Study Sites (2)
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
Philadelphia, Pennsylvania, 19104, United States
Penn Medicine at Radnor, 250 King of Prussia Road
Radnor, Pennsylvania, 19087, United States
Related Publications (1)
Gracia CR, Sammel MD, Freeman E, Prewitt M, Carlson C, Ray A, Vance A, Ginsberg JP. Impact of cancer therapies on ovarian reserve. Fertil Steril. 2012 Jan;97(1):134-40.e1. doi: 10.1016/j.fertnstert.2011.10.040. Epub 2011 Dec 2.
PMID: 22137491BACKGROUND
Related Links
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clarisa R Gracia, MD, MSCE
University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 14, 2010
Study Start
March 1, 2006
Primary Completion
March 30, 2020
Study Completion
March 30, 2020
Last Updated
April 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.