Assessing Fertility Potential in Female Cancer Survivors

Effects of Chemotherapy Clinical Trial

Official title:

Assessing Fertility Potential in Female Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143844
• Other study ID #: 804237
• Secondary ID: UPCC12807
• Status: Completed
• Start date: March 2006
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Effects of Chemotherapy

Locations

Country	Name	City	State
United States	Penn Reproductive Research Unit, 3701 Market Street, Suite 810	Philadelphia	Pennsylvania
United States	Penn Medicine at Radnor, 250 King of Prussia Road	Radnor	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproductive hormones	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).	Annually for 3-5 years
Secondary	Antral Follicle Counts	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.	Annually for 3-5 years

External Links

•   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.