Ovarian Reserve After Cancer: Longitudinal Effects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium

Conditions
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Effects of Chemotherapy, Premature Ovarian Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for exposed population: Postmenarchal females to be treated with chemotherapy between the ages of 11-35 years, with a uterus and at least one ovary Inclusion Criteria for unexposed population: healthy postmenarchal females no prior or planned exposure to chemotherapy between the ages of 11-35, with a uterus and at least one ovary regular menstrual cycles (21-35 days) Exclusion criteria for all subjects: positive pregnancy test at enrollment lactation within the previous 1 month, previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer. previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier) endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia). Additional exclusions for the unexposed population: a history of infertility, defined as at least 12 months of unprotected intercourse without conception polycystic ovary syndrome (PCOS)

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>Females ages 11-35 to be exposed to alkylating agent chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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new diagnosis of cancer, chemotherapy, oncofertility, alkylating agent, fertility preservation, fertility after cancer, late effects