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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
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Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.
A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment.
Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed | Females ages 11-35 to be exposed to alkylating agent chemotherapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in reproductive hormone measures, during and after chemotherapy. | 20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern. | 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in antral follicle counts, during and after chemotherapy. | 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. | 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in menstrual function, during and after chemotherapy | Subjects are asked to document menstrual bleeding in a diary, noting duration of each menstrual period in days, bleeding intensity (spotting, light, moderate, heavy, flooding, none), and intervals between periods. | 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. |
Inclusion Criteria for exposed population:
Inclusion Criteria for unexposed population:
Exclusion criteria for all subjects:
Additional exclusions for the unexposed population:
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Postmenarchal females, ages 11-35, who will require chemotherapy; An unexposed cohort balanced to the exposed cohort with respect to age and oral contraceptive use.
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| Name | Affiliation | Role |
|---|---|---|
| Clarisa R Gracia, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, Reproductive Research Unit | Philadelphia | Pennsylvania | 19104-5509 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23084267 | Background | Dillon KE, Sammel MD, Prewitt M, Ginsberg JP, Walker D, Mersereau JE, Gosiengfiao Y, Gracia CR. Pretreatment antimullerian hormone levels determine rate of posttherapy ovarian reserve recovery: acute changes in ovarian reserve during and after chemotherapy. Fertil Steril. 2013 Feb;99(2):477-83. doi: 10.1016/j.fertnstert.2012.09.039. Epub 2012 Oct 18. | |
| 30566616 |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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whole blood, serum
| Change from baseline in menopausal symptoms during and after chemotherapy. | The validated "Menopausal Symptom List" (MSL) will be used at each study visit to assess the presence or absence of menopausal symptoms during the past month, the frequency and severity of each symptom. Symptoms captured include: hot flashes, vaginal dryness, concentration/memory problems, irritability, mood swings, feeling sad, feeling anxious, trouble sleeping, aches, joint pain, headaches. | 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. |
| Change from baseline in ovarian volume during and after chemotherapy. | Ovaries will be measured in three dimensions. Uterine size and endometrial thickness will also be performed. The transvaginal approach is preferred, but transabdominal ultrasound will be performed in girls who do not feel comfortable with the transvaginal procedure. | 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy. |
| Cameron K, Sammel MD, Prewitt M, Gracia C. Differential Rates of Change in Measures of Ovarian Reserve in Young Cancer Survivors Across the Reproductive Lifespan. J Clin Endocrinol Metab. 2019 May 1;104(5):1813-1822. doi: 10.1210/jc.2018-02257. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |