NCT01268592TerminatedNot Applicable
Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Northwell Health
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- successful pregnancy
Study Overview
Brief Summary
The purpose of this study is to preserve the fertility potential in females diagnosed with cancer by vitrifying (rapidly freezing) their oocytes (eggs) before undergoing treatment for their cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 42 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be 14-42 year old females with a cancer diagnosis.
- •Clearance letter from treating oncologist.
- •Approval by program oncologist or her designee.
- •Informed consent has to be signed after consultation with the program physician. Minors require consent of a parent or a legal guardian and assent from the participant.
- •Life expectancy (predicted by their malignancy) of 5 or more years.
- •Cancer diagnosis should have an expected cure rate of 50% or more, based upon clinico-pathologic features.
Exclusion Criteria
- •Patients whose oncologist and the program oncologist concur that immediate oncologic care should be rendered, not allowing sufficient time for a course of gonadotropin therapy and egg retrieval.
- •FSH level >20 MIU/ml, indicating abnormal ovarian function.
- •Patients with stage IV cancers (*age appropriate women with stage IV advanced Hodgkin's Lymphoma will be considered, as there is a significant long term survival rate with this advanced disease).
- •Patients with incurable cancer diagnoses.
- •Patients who are unable or unwilling to sign the informed consent.
- •Women cannot have an embryo transfer beyond age 50.
Outcomes
Primary Outcomes
successful pregnancy
Time Frame: nine months after transfer of embryo(s)
the primary objective of this study is the establishment of a successful pregnancy, following a disease-free interval after treatment for her cancer; this interval will be patient-dependent and will undoubtedly vary between participants.
Secondary Outcomes
- impact of stimulation on cancer recurrence(5 years after treatment)
Investigators
Study Sites (2)
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