Ovarian Reserve After Cancer: Longitudinal Effects



Status:Active, not recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:11 - 35
Updated:6/27/2018
Start Date:February 2009
End Date:December 2020

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

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.

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)
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Clarisa R Gracia, MD, MSCE
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mi
from
Philadelphia, PA
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