Oocyte Cryopreservation (egg freezing)

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:
NCT01232972
First received: October 29, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention
Fertility
Procedure: vitrification of oocytes

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Oocyte Cryopreservation

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

Primary Outcome Measures:
  • Successful pregnancy [ Time Frame: until the patient reaches 50 years of age ] [ Designated as safety issue: No ]
    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:
  • oocyte survival [ Time Frame: up to 50 years of age ] [ Designated as safety issue: No ]
    the number of eggs that successfully survive the frozen-thawing procedure (vitrification).

  • fertilization [ Time Frame: up to 50 years of age ] [ Designated as safety issue: No ]
    to calculate the rate for the number of oocytes that are successfully fertilized (via ICSI) following survival of the frozen-thaw procedure.

  • blastocyst formation [ Time Frame: up to 50 years of age ] [ Designated as safety issue: No ]
    calculates the number of successfully fertilized embryos that grow into blastocysts (day 5 of culture), created from eggs that underwent and survived vitrification.

  • implantation [ Time Frame: up to 50 years of age ] [ Designated as safety issue: No ]
    to determine the implantation rate of embryos that were created from vitrified oocytes.


Enrollment: 23
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: 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

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232972

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:
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
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: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01232972     History of Changes
Other Study ID Numbers: 10-203A
Study First Received: October 29, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
vitrification
egg freezing
oocyte cryopreservation
female fertility potential
fertility preservation
Fertility preservation, female

ClinicalTrials.gov processed this record on September 18, 2014