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Assessing Fertility Potential in Female Cancer Survivors

This study is currently recruiting participants.
Verified June 2010 by University of Pennsylvania
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01143844
First received: June 11, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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 5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood tests (FSH, Estradiol, AMH and Inhibin B) 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.

Participants ages 18-40 in this study will have the option of undergoing an additional, more sensitive test to assess their ovarian function. This test is called the clomiphene citrate (clomid) challenge test and involves taking clomiphene citrate for five days and having a repeat blood draw on the 10th day of the menstrual cycle.


Condition
History of Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessing Fertility Potential in Female Cancer Survivors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 291
Study Start Date: March 2006
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cancer survivors, ages 15-40
  • Prior exposure to alkylating agent chemotherapy and/or radiation therapy
  • At least 1 year from completion of cancer 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, Late Reproductive Aged women, ages 41-50
  • 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 peers, ages 15-40
  • 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).

Detailed Description:

A total of 291 females will participate in this study: 3 groups with 97 women in each group.

  • Cancer survivors, ages 15-40, who have been exposed to alkylating agent chemotherapy and/or radiation therapy
  • Unexposed peers, ages 15-40, never exposed to chemotherapy or radiation therapy
  • Late Reproductive Aged volunteers, ages 41-50 never exposed to chemotherapy or radiation therapy
  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with a history of cancer 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.

Criteria

Inclusion Criteria for cancer survivors:

  • Previous treatment with chemotherapy and/or radiation therapy for either cancer or another illness.
  • Age between 15-40 years.
  • Post-menarchal.
  • Presence of a uterus and at least one ovary.
  • Ability and willingness to comply with stuy 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 15 and 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.

Additional inclusion criteria for clomiphene citrate sub-study:

  • Age between 18 and 42 years.

Additional exclusion criteria for the clomiphene citrate sub-study:

  • Known allergy or hypersensitivity to clomiphene citrate.
  • History of liver dysfunction.
  • Abnormal uterine bleeding.
  • Ovarian cysts
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143844

Contacts
Contact: Maureen Prewitt, BA, BSN, RN 215-615-4889; 215-662-7727 prewittm@uphs.upenn.edu

Locations
United States, Pennsylvania
Penn Reproductive Research Unit, 3701 Market Street, Suite 810 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vivian Conti     215-662-7727        
Principal Investigator: Clarisa Gracia, MD, MSCE            
Penn Medicine at Radnor, 250 King of Prussia Road Recruiting
Radnor, Pennsylvania, United States, 19087
Principal Investigator: Clarisa Gracia, MD, MSCE            
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
  More Information

Additional Information:
Select "Clinical Trials" for Current Studies at Penn's Women's Health Clinical Research Center.For more information about participating in one of Penn Fertility Care's research studies please call 1-800-789-PENN.  This link exits the ClinicalTrials.gov site

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clarisa R. Gracia, MD, MSCE, Universtiy of Pennsylvania
ClinicalTrials.gov Identifier: NCT01143844     History of Changes
Other Study ID Numbers: 804237, UPCC12807
Study First Received: June 11, 2010
Last Updated: June 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
radiation therapy
early menopause
Oncofertility
Fertility
Late effects
cancer
chemotherapy
 survivor
ovarian reserve
premature ovarian failure
healthy volunteers
perimenopause
middle age
pediatric survivors

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013