Status:
COMPLETED
Assessing Fertility Potential in Female Cancer Survivors
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Children's Hospital of Philadelphia
Conditions:
Effects of Chemotherapy
Eligibility:
FEMALE
11-50 years
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 w...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for cancer survivors:
- 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prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Inclusion Criteria for controls:
- 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prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT01143844
Start Date
March 1 2006
End Date
March 30 2020
Last Update
April 13 2021
Active Locations (2)
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1
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
Philadelphia, Pennsylvania, United States, 19104
2
Penn Medicine at Radnor, 250 King of Prussia Road
Radnor, Pennsylvania, United States, 19087