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Fertility Preservation in Female Cancer Patients

This study has been terminated.
(Study technique has been declared part of standard care)
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01268592
First received: November 1, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Fertility
 Procedure: oocyte vitrification

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential

Resource links provided by NLM:

MedlinePlus related topics: Cancer Infertility
U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • successful pregnancy [ Time Frame: nine months after transfer of embryo(s) ] [ Designated as safety issue: No ]
    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:
  • impact of stimulation on cancer recurrence [ Time Frame: 5 years after treatment ] [ Designated as safety issue: Yes ]
    patients will be followed for five years following cancer treatment to assess the risks associated with ovarian stimulation and the recurrence of cancer.


Enrollment: 16
Study Start Date: October 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   14 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268592

Locations
United States, New York
Center for Human Reproduction
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Avner Hershlag, MD Center for Human Reproduction
  More Information

Publications:
Kumayama M and Kato O. All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447, 2000.

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01268592     History of Changes
Other Study ID Numbers: 10-204A
Study First Received: November 1, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
fertility preservation
oocyte cryopreservation
vitrification
egg freezing
fertility preservation in female cancer patients

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013