Ovarian Reserve After Cancer: Longitudinal Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2028-12-31

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.

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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.

Conditions

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Effects of Chemotherapy Premature Ovarian Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed

Females ages 11-35 to be exposed to alkylating agent chemotherapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Postmenarchal females to be treated with chemotherapy
* between the ages of 11-35 years,
* with a uterus and at least one ovary

* 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

* 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)

Minimum Eligible Age

11 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes