Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Premature Birth

Primary Ovarian Insufficiency

Menopause, Premature

Menopause

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Reproductive Control Agents

Hormones

Epinephrine

Racepinephrine

Epinephryl borate

Contraceptive Agents

Contraceptives, Oral

Alkylating Agents

* 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).

* 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).

Clarisa R Gracia, MD, MSCE

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

Assessing Fertility Potential in Female Cancer Survivors

Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessing Fertility Potential in Female Cancer Survivors	NCT01143844	Effects of Chem...		11 Years - 50 Years	University of Pennsylvania
Assessing Fertility Potential in Female Cancer Survivors	NCT01143844	Effects of Chem...		11 Years - 50 Years	University of Pennsylvania

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