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.

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Key information

Conditions

Effects of Chemotherapy Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

11 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Penn Reproductive Research Unit, 3701 Market Street, Suite 810, Philadelphia, Pennsylvania, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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).

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

Children's Hospital of Philadelphia

Registry information

Important dates

Study start: 2006
Primary completion: 2020
Study completion: 2020
First posted: Jun 14, 2010
Registry last updated: Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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