Assessing Fertility Potential in Female Cancer Survivors

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01143844
Collaborator
Children's Hospital of Philadelphia (Other)
391
2
169
195.5
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 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 Design

    Study Type:
    Observational
    Actual Enrollment :
    391 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Assessing Fertility Potential in Female Cancer Survivors
    Actual Study Start Date :
    Mar 1, 2006
    Actual Primary Completion Date :
    Mar 30, 2020
    Actual Study Completion Date :
    Mar 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Reproductive hormones [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).

    Secondary Outcome Measures

    1. Antral Follicle Counts [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • University of Pennsylvania
    • Children's Hospital of Philadelphia

    Investigators

    • Principal Investigator: Clarisa R Gracia, MD, MSCE, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT01143844
    Other Study ID Numbers:
    • 804237
    • UPCC12807
    First Posted:
    Jun 14, 2010
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Pennsylvania

    Study Results

    No Results Posted as of Apr 13, 2021