Assessing Fertility Potential in Female Cancer Survivors

Completed

• Conditions: Effects of Chemotherapy

• Registration Number: NCT01143844
• Lead Sponsor: University of Pennsylvania

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 391

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

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