Fertility Preservation in Female Cancer Patients

April 22, 2013 updated by: Northwell Health

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Center for Human Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 42 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: positive cancer diagnosis
female patients diagnosed with cancer who wish to preserve their fertility by vitrifying their oocytes
Procedure: oocyte vitrification
freezing of the patient's retrieved oocytes via vitrification (rapid freezing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
nine months after transfer of embryo(s)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of stimulation on cancer recurrence
Time Frame: 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.
5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Avner Hershlag, MD, Center for Human Reproduction

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

December 29, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

April 23, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-204A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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