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Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

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ClinicalTrials.gov Identifier: NCT00777387
Recruitment Status : Terminated (Studies emerged that demonstrated the superiority of vitrification)
First Posted : October 22, 2008
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Ellen Greenblatt, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary:

Preservation of fertility is limited. Current methods include embryo cryopreservation and while still experimental, ovarian cryopreservation. In single women who are at risk for infertility secondary to cancer or couples who have ethical reasons to avoid embryo cryopreservation, oocyte cryopreservation is an alternative Purpose of study is to compare slow freeze to vitrification of human oocytes. Successful cryopreservation and subsequent thawing programs are characterized by avoiding ice crystal formation.Vitrification, newer alternative to slow freeze method, process by which water is prevented from forming ice.

Our hypothesis is that higher survival rate per oocyte is to be expected in the vitrification group.


Condition or disease Intervention/treatment Phase
Infertility Procedure: slow-freeze Procedure: vitrification Not Applicable

Detailed Description:
Although several reviews of smaller studies of cryoprotectant methodology exist randomized controlled trials,comparing slow-freeze-rapid-thaw procedure to vitrification of oocytes, are not available. The purpose of this study is to compare these two methods of oocyte cryopreservation in human oocytes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-freezing to Vitrification
Study Start Date : August 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: 1
slow-freeze
Procedure: slow-freeze
Slow-freeze-rapid-thaw procedure of oocytes is characterized by prolonged exposure of the cell to cryoprotectants in a low metabolic state at very low temperatures

Active Comparator: 2
vitrification
Procedure: vitrification
Vitrification is the process by which water is prevented from forming ice due to the viscosity of a highly concentrated cryoprotectant cooled at an extremely rapid rate




Primary Outcome Measures :
  1. post-thaw oocyte survival rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. fertilization rate [ Time Frame: 2 years ]
  2. cleavage [ Time Frame: 2 years ]
  3. embryo development [ Time Frame: 2 years ]
  4. implantation rate [ Time Frame: 2 years ]
  5. ongoing pregnancy [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 14 or more oocytes at ovum pick up
  • age < 38
  • bmi < 30

Exclusion Criteria:

-


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 ClinicalTrials.gov identifier (NCT number): NCT00777387


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Study Director: Ellen M Greenblatt, MD, FRCS(C) Mount Sinai Hospital, Canada
Publications:
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Responsible Party: Ellen Greenblatt, Associate Professor, U of T, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00777387    
Other Study ID Numbers: oocyte cryopreservation
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014
Keywords provided by Ellen Greenblatt, Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
human oocyte cryopreservation
slow-freeze
vitrification
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female