Randomized Controlled Trial Comparing Slow-freezing to Vitrification of Oocytes

NCT ID: NCT00777387

Last Updated: 2014-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

slow-freeze

Group Type ACTIVE_COMPARATOR

slow-freeze

Intervention Type PROCEDURE

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

2

vitrification

Group Type ACTIVE_COMPARATOR

vitrification

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ellen Greenblatt

Associate Professor, U of T

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen M Greenblatt, MD, FRCS(C)

Role: STUDY_DIRECTOR

Mount Sinai Hospital, Canada

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 17846105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16735826 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16818031 (View on PubMed)

Jain JK, Paulson RJ. Oocyte cryopreservation. Fertil Steril. 2006 Oct;86(4 Suppl):1037-46. doi: 10.1016/j.fertnstert.2006.07.1478.

Reference Type BACKGROUND
PMID: 17008147 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1550144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14967351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11155951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16720842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12798878 (View on PubMed)

Other Identifiers

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oocyte cryopreservation

Identifier Type: -

Identifier Source: org_study_id

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