Randomized Controlled Trial Comparing Slow-Freezing to Vitrification of Oocytes

Condition(s) targeted: Infertility

Intervention: slow-freeze (Procedure); vitrification (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Official(s) and/or principal investigator(s):
Ellen M Greenblatt, MD, FRCS(C), Study Director, Affiliation: Mount Sinai Hospital Toronto

Overall contact:
Ellen M Greenblatt, MD, FRCS(C), Phone: 416-586-4748, Email: egreenblatt@mtsinai.on.ca

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.

Official title: Cryopreservation of Oocytes: A Randomized Controlled Trial Comparing Slow-Freezing to Vitrification

Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: post-thaw oocyte survival rate

Secondary outcome:

fertilization rate

cleavage

embryo development

implantation rate

ongoing pregnancy

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.

Minimum age: 18 Years. Maximum age: 37 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- 14 or more oocytes at ovum pick up

- age < 38

- bmi < 30

Exclusion Criteria:

-

Ellen M Greenblatt, MD, FRCS(C), Phone: 416-586-4748, Email: egreenblatt@mtsinai.on.ca

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

Related publications:

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

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.

Starting date: August 2008
Ending date: December 2010
Last updated: October 20, 2008