Fertility Preservation in Female Cancer Patients

Not Applicable

Terminated

• Conditions: Fertility
• Interventions: Procedure: oocyte vitrification

• Registration Number: NCT01268592
• Lead Sponsor: Northwell Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-31
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
positive cancer diagnosis	oocyte vitrification	female patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes

Primary Outcome Measures

Name	Time	Method
successful pregnancy	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 Outcome Measures

Name	Time	Method
impact of stimulation on cancer recurrence	5 years after treatment	patients will be followed for five years following cancer treatment to assess the risks associated with ovarian stimulation and the recurrence of cancer.

Trial Locations

Locations (1)

Center for Human Reproduction; 🇺🇸 Manhasset, New York, United States