Assessing Fertility Potential in Female Cancer Survivors

NCT ID: NCT01143844

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 391 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2020-03-30

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.

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

Conditions

Effects of Chemotherapy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clarisa R Gracia, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Penn Reproductive Research Unit, 3701 Market Street, Suite 810

Philadelphia, Pennsylvania, United States

Penn Medicine at Radnor, 250 King of Prussia Road

Radnor, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22137491 (View on PubMed)

Related Links

http://www.pennmedicine.org/fertility/

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.

Other Identifiers

UPCC12807

Identifier Type: OTHER

Identifier Source: secondary_id

804237

Identifier Type: -

Identifier Source: org_study_id