Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential

Northwell Health1 site in 1 country16 target enrollmentOctober 2010

ConditionsFertility

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fertility
Sponsor: Northwell Health
Enrollment: 16
Locations: 1
Primary Endpoint: successful pregnancy
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

March 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Northwell Health

Responsible Party

Sponsor

Eligibility Criteria

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.