Oocyte Cryopreservation (egg freezing)

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: NCT01232972
Recruitment Status : Terminated (Study technique has been declared part of standard care)
First Posted : November 2, 2010
Last Update Posted : April 23, 2013
Information provided by (Responsible Party):
Northwell Health

Brief Summary:
The purpose of this investigation is to offer the opportunity for young women to cryopreserve (freeze) their oocytes (eggs) for use with IVF at a later point in time.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oocyte Cryopreservation
Study Start Date : October 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: oocyte freezing
includes any women who elects to preserve her fertility by vitrifying her unfertilized eggs.
Procedure: vitrification of oocytes
eggs will be preserved via vitrification the day they are retrieved from the participant

Primary Outcome Measures :
  1. Successful pregnancy [ Time Frame: until the patient reaches 50 years of age ]
    Eggs will be frozen via vitrification for those females electing to preserve their fertility; patients will return following an unspecified time period, when they are ready to use their frozen eggs. At that time, the eggs will be thawed and fertilized (with the sperm source of the participant's choice) to create embryos. This time frame will be unique to each individual; however, the Center has a policy whereby no embryo transfer will be performed beyond the age of fifty (50).

Secondary Outcome Measures :
  1. oocyte survival [ Time Frame: up to 50 years of age ]
    the number of eggs that successfully survive the frozen-thawing procedure (vitrification).

  2. fertilization [ Time Frame: up to 50 years of age ]
    to calculate the rate for the number of oocytes that are successfully fertilized (via ICSI) following survival of the frozen-thaw procedure.

  3. blastocyst formation [ Time Frame: up to 50 years of age ]
    calculates the number of successfully fertilized embryos that grow into blastocysts (day 5 of culture), created from eggs that underwent and survived vitrification.

  4. implantation [ Time Frame: up to 50 years of age ]
    to determine the implantation rate of embryos that were created from vitrified oocytes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • women between the ages of 18 and 42
  • election to preserve fertility by freezing eggs

Exclusion Criteria:

  • women over the age of 43
  • patient unwilling to sign informed consent

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): NCT01232972

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

Nagy ZP, Diaz DG, Diaz R, Bennett A, Al-Sabagh R, V Maamari. Human oocyte preservation (Hope): preliminary results. Fertil Steril 92, Supp3:S189, 2009
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.
Fioravanti J, Alegretti JR, Hassun PA, Motta ELA, Serafini PC and Smith GD. Prospective randomized comparison of human oocyte freezing and vitrification: an update. Fertil Steril 88, Suppl 1:S13, 2007.

Responsible Party: Northwell Health Identifier: NCT01232972     History of Changes
Other Study ID Numbers: 10-203A
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Northwell Health:
egg freezing
oocyte cryopreservation
female fertility potential
fertility preservation
Fertility preservation, female