Randomized Controlled Trial Comparing Slow-Freezing to Vitrification of Oocytes - Full Text View

Sponsor:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00777387

Purpose

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	Intervention
Infertility	Procedure: slow-freeze Procedure: vitrification

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-Freezing to Vitrification

Resource links provided by NLM:

MedlinePlus related topics: Infertility

U.S. FDA Resources

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:

post-thaw oocyte survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

fertilization rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
cleavage [ Time Frame: 2 years ] [ Designated as safety issue: No ]
embryo development [ Time Frame: 2 years ] [ Designated as safety issue: No ]
implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
ongoing pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	134
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 37 Years
Genders 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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777387

Contacts

Contact: Ellen M Greenblatt, MD, FRCS(C)	416-586-4748	egreenblatt@mtsinai.on.ca
Contact: Tina R Lo, MD	647-339-9563	tlo2@mtsinai.on.ca

Locations

Canada, Ontario
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1Z5
Contact: Tina R Lo, MD 647-339-9563 tlo2@mtsinai.on.ca
Principal Investigator: Ellen M Greenblatt, MD,FRCS(C)

Sponsors and Collaborators

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

Study Director:

Ellen M Greenblatt, MD, FRCS(C)

Mount Sinai Hospital, Toronto

More Information

Publications:

Gook DA, Edgar DH. Human oocyte cryopreservation. Hum Reprod Update. 2007 Nov-Dec;13(6):591-605. Epub 2007 Sep 10. Review.

Porcu E, Venturoli S. Progress with oocyte crypreservation. Current Opinion Obstetrics Gyneacolgy 2006;18:273-9

Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril. 2006 Jul;86(1):70-80.

Jain k, Paulson RJ. Oocyte cryopreservation. Fertility and Sterility 2006;86 suppl 4:1037-46

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.

Falcone T, Attaran M, Bedaiwy MA, Goldberg JM. Ovarian function preservation in the cancer patient. Fertil Steril. 2004 Feb;81(2):243-57. Review.

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. Review.

Sonmezer M, Oktay K. Fertility preservation in young women undergoing breast cancer therapy. Oncologist. 2006 May;11(5):422-34. Review.

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.

Responsible Party:	Dr Ellen Greenblatt/ Clinical director Reproductive Biology Unit, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00777387 History of Changes
Other Study ID Numbers:	oocyte cryopreservation
Study First Received:	October 20, 2008
Last Updated:	October 20, 2008
Health Authority:	Canada: Health Canada

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

human oocyte cryopreservation
slow-freeze
vitrification

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012