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Assessing Fertility Potential in Female Cancer Survivors

This study is currently recruiting participants.
Verified August 2016 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143844
First Posted: June 14, 2010
Last Update Posted: August 25, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Pennsylvania
June 11, 2010
June 14, 2010
August 25, 2016
March 2006
July 2018   (Final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT01143844 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Assessing Fertility Potential in Female Cancer Survivors
Assessing Fertility Potential in Female Cancer Survivors

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.

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
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Serum
Non-Probability Sample
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.
Effects of Chemotherapy
Not Provided
  • 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).
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
July 2018
July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
11 Years to 50 Years   (Child, Adult)
Yes
Contact: Maureen Prewitt, BSN 215-614-1414 prewittm@uphs.upenn.edu; PennOncoFertility@uphs.upenn.edu
United States
 
 
NCT01143844
804237
UPCC12807 ( Other Identifier: University of Pennsylvania Abramson Cancer Center )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.
University of Pennsylvania
University of Pennsylvania
Children's Hospital of Philadelphia
Principal Investigator: Clarisa R Gracia, MD, MSCE University of Pennsylvania
University of Pennsylvania
August 2016