Fertility Preservation in Female Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01268592
Recruitment Status : Terminated (Study technique has been declared part of standard care)
First Posted : December 31, 2010
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fertility Procedure: oocyte vitrification Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential
Study Start Date : October 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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)

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

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Ages Eligible for Study:   14 Years to 42 Years   (Child, Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01268592

United States, New York
Center for Human Reproduction
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Principal Investigator: Avner Hershlag, MD Center for Human Reproduction

Kumayama M and Kato O. All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447, 2000.
Nagy ZP, Chang CC, Bernal DP, Shapiro D, Mitchell-Leef D and Kort HI. Comparison of laboratory and clinical outcomes between fresh and vitrified sibling oocytes obtained from 30-39 year old IVF patients. Fertil Steril 92, Supp3:S67, 2009.

Responsible Party: Northwell Health Identifier: NCT01268592     History of Changes
Other Study ID Numbers: 10-204A
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Northwell Health:
fertility preservation
oocyte cryopreservation
egg freezing
fertility preservation in female cancer patients