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Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
slow-freeze
vitrification
Sponsored by
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring human oocyte cryopreservation, slow-freeze, vitrification

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

slow-freeze

vitrification

Outcomes

Primary Outcome Measures

post-thaw oocyte survival rate

Secondary Outcome Measures

fertilization rate
cleavage
embryo development
implantation rate
ongoing pregnancy

Full Information

First Posted
October 20, 2008
Last Updated
January 6, 2014
Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00777387
Brief Title
Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes
Official Title
Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-freezing to Vitrification
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Studies emerged that demonstrated the superiority of vitrification
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
human oocyte cryopreservation, slow-freeze, vitrification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
slow-freeze
Arm Title
2
Arm Type
Active Comparator
Arm Description
vitrification
Intervention Type
Procedure
Intervention Name(s)
slow-freeze
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
vitrification
Intervention Description
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 Measure Information:
Title
post-thaw oocyte survival rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
fertilization rate
Time Frame
2 years
Title
cleavage
Time Frame
2 years
Title
embryo development
Time Frame
2 years
Title
implantation rate
Time Frame
2 years
Title
ongoing pregnancy
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 14 or more oocytes at ovum pick up age < 38 bmi < 30 Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen M Greenblatt, MD, FRCS(C)
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17846105
Citation
Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. doi: 10.1093/humupd/dmm028. Epub 2007 Sep 10.
Results Reference
background
PubMed Identifier
16735826
Citation
Porcu E, Venturoli S. Progress with oocyte cryopreservation. Curr Opin Obstet Gynecol. 2006 Jun;18(3):273-9. doi: 10.1097/01.gco.0000193015.96275.2d.
Results Reference
background
PubMed Identifier
16818031
Citation
Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril. 2006 Jul;86(1):70-80. doi: 10.1016/j.fertnstert.2006.03.017.
Results Reference
background
PubMed Identifier
17008147
Citation
Jain JK, Paulson RJ. Oocyte cryopreservation. Fertil Steril. 2006 Oct;86(4 Suppl):1037-46. doi: 10.1016/j.fertnstert.2006.07.1478.
Results Reference
background
PubMed Identifier
1550144
Citation
Byrne J, Fears TR, Gail MH, Pee D, Connelly RR, Austin DF, Holmes GF, Holmes FF, Latourette HB, Meigs JW, et al. Early menopause in long-term survivors of cancer during adolescence. Am J Obstet Gynecol. 1992 Mar;166(3):788-93. doi: 10.1016/0002-9378(92)91335-8.
Results Reference
background
PubMed Identifier
14967351
Citation
Falcone T, Attaran M, Bedaiwy MA, Goldberg JM. Ovarian function preservation in the cancer patient. Fertil Steril. 2004 Feb;81(2):243-57. doi: 10.1016/j.fertnstert.2003.06.031.
Results Reference
background
PubMed Identifier
11155951
Citation
Porcu E, Fabbri R, Damiano G, Giunchi S, Fratto R, Ciotti PM, Venturoli S, Flamigni C. Clinical experience and applications of oocyte cryopreservation. Mol Cell Endocrinol. 2000 Nov 27;169(1-2):33-7. doi: 10.1016/s0303-7207(00)00348-8.
Results Reference
background
PubMed Identifier
16720842
Citation
Sonmezer M, Oktay K. Fertility preservation in young women undergoing breast cancer therapy. Oncologist. 2006 May;11(5):422-34. doi: 10.1634/theoncologist.11-5-422.
Results Reference
background
PubMed Identifier
12798878
Citation
Yoon TK, Kim TJ, Park SE, Hong SW, Ko JJ, Chung HM, Cha KY. Live births after vitrification of oocytes in a stimulated in vitro fertilization-embryo transfer program. Fertil Steril. 2003 Jun;79(6):1323-6. doi: 10.1016/s0015-0282(03)00258-9.
Results Reference
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Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

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