NCT00777387

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

5.4 years

First QC Date

October 20, 2008

Last Update Submit

January 6, 2014

Conditions

Infertility

Keywords

human oocyte cryopreservationslow-freezevitrification

Outcome Measures

Primary Outcomes (1)

  • post-thaw oocyte survival rate

    2 years

Secondary Outcomes (5)

  • fertilization rate

    2 years

  • cleavage

    2 years

  • embryo development

    2 years

  • implantation rate

    2 years

  • ongoing pregnancy

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

slow-freeze

Procedure: slow-freeze

2

ACTIVE COMPARATOR

vitrification

Procedure: vitrification

Interventions

slow-freezePROCEDURE

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

1
vitrificationPROCEDURE

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

2

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

Related Publications (9)

  • 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.

    PMID: 17846105BACKGROUND

  • 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.

    PMID: 16735826BACKGROUND

  • 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.

    PMID: 16818031BACKGROUND

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

    PMID: 17008147BACKGROUND

  • 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.

    PMID: 1550144BACKGROUND

  • 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.

    PMID: 14967351BACKGROUND

  • 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.

    PMID: 11155951BACKGROUND

  • 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.

    PMID: 16720842BACKGROUND

  • 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.

    PMID: 12798878BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Vitrification

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Phase TransitionPhysical Phenomena

Study Officials

  • Ellen M Greenblatt, MD, FRCS(C)

    Mount Sinai Hospital, Canada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, U of T

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 22, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

CA(1)