A Comparison of Two Freezing Techniques

NCT00852306 | Completed

• 1 other identifier: 08-265
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.

Conditions

Infertility

Keywords

oocyte freezing; vitrification; slow freeze; fertility preservation

Outcome Measures

Primary Outcomes (1)

• Achievement of a pregnancy, as determined by a fetal heartbeat

  2 months

Secondary Outcomes (4)

• Percentage of eggs that result in blastocyst formation

  1 week

• Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure)

  2 days

• ICSI fertilization rate (percentage of eggs that fertilize)

  2 days

• Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized)

  2 days

Study Arms (2)

slow freeze

EXPERIMENTAL

these recipients will have their first embryo transfer with oocytes frozen via the slow freeze method.

Procedure: oocyte freezing

vitrification

EXPERIMENTAL

these recipients will have their first attempt at an embryo transfer with oocytes frozen via the vitrification method.

Procedure: oocyte freezing

Interventions

oocyte freezing PROCEDURE

retrieved oocytes from the donor will be split in half and frozen by both existing egg freezing methods: slow freezing and vitrification. The recipients will then be randomized as to which group of eggs will be thawed out for their first attempt at achieving a pregnancy.

slow freeze; vitrification

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• donors: women ages 21-32 who wish to donate their eggs; must pass medical, physical and psychological screening.
• recipients: women under the age of 50 who wish to have eggs donated to them through the Donor Egg Program and who aslo pass the medical, physical and psychological screening.

You may not qualify if:

• donors: those who do not pass the genetic screening or psychological testing, as described below
• recipients: those who do not pass the screening.
• The genetic screening of donors will involve the following:
• All donors will be screened for Cystic Fibrosis, Fragile X and Spinomuscular Atrophy (SMA).
• In addition, donors of Ashkenazi Jewish origin will be screened for Gaucher's disease, Canavan,Tay -Sachs, Familial Dysautonomia, Niemann Pick, Fanconi's Anemia, Bloom and Mucolipidosis Type IV.
• Donors of African-American origin will be screened for Sickle-Cell disease.
• Donors of Asian, Mediterranean, Latino or Hispanic origins will be screened for Thalassemia.
• Recipient Screening: A Reproductive Endocrinologist (RE) at the Center will take a detailed history and perform a physical examination on all potential recipients. The RE will assess the health of the potential recipient in order to assess her capacity to carry a pregnancy. Previous IVF cycles, successful or unsuccessful, will have no implication on recipient selection.
• The recipient and her partner (if applicable) will meet with the program psychologist. The psychological evaluation is detailed below.
• Psychological evaluation: A psychological evaluation will be conducted of the Recipient, her partner (if applicable) and the Donor. The purpose of these evaluations is to determine the suitability of the parties to participate in the Donor Egg Program. Psychological tests will be administered by the Center as part of the evaluation process.
• These evaluations may result in a recommendation that one and/or all of the parties not participate in the Donor Egg Program. The psychologist will not be providing any advice or treatment to the Donor or Recipient(s). Nor will the Donor or Recipient(s) be entitled to the results of the Psychologist's evaluation. The Psychologist will provide the results of his/her evaluations to the Center for Human Reproduction.
• As with our standard Donor Egg Program practices, there will be an upper age limit of 50 years for all recipients participating in the study.

Sponsors & Collaborators

• Northwell Health: lead
• EMD Serono: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Related Publications (21)

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  BACKGROUND

• Smith GD, Serafini PC, Fioravanti J, Yadid I, Coslovsky M, Hassun P, Alegretti JR, Motta EL. Prospective randomized comparison of human oocyte cryopreservation with slow-rate freezing or vitrification. Fertil Steril. 2010 Nov;94(6):2088-95. doi: 10.1016/j.fertnstert.2009.12.065. Epub 2010 Feb 19.

  PMID: 20171613 BACKGROUND

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  PMID: 12832365 BACKGROUND

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  PMID: 17846105 BACKGROUND

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  PMID: 11821076 BACKGROUND

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  PMID: 17008147 BACKGROUND

• Kumayama M and Kato O (2000a) Successful vitrification of human oocytes. Fertil Steril 74, Suppl 3:S49.

  BACKGROUND

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  BACKGROUND

• Kuzan FB and Quinn P (1988) Cryopreservation of mammalian embryos IN in vitro fertilization and embryo transfer: a manual of basic techniques. Plenum Press, New York.

  BACKGROUND

• Li Y, Feng HL, Cao YJ, Zheng GJ, Yang Y, Mullen S, Critser JK, Chen ZJ. Confocal microscopic analysis of the spindle and chromosome configurations of human oocytes matured in vitro. Fertil Steril. 2006 Apr;85(4):827-32. doi: 10.1016/j.fertnstert.2005.06.064.

  PMID: 16580356 BACKGROUND

• Nagy ZP, Chang CC, Shapiro DB, Bernal DP, Elsner CW, Mitchell-Leef D, Toledo AA, Kort HI. Clinical evaluation of the efficiency of an oocyte donation program using egg cryo-banking. Fertil Steril. 2009 Aug;92(2):520-6. doi: 10.1016/j.fertnstert.2008.06.005. Epub 2008 Aug 9.

  PMID: 18692830 BACKGROUND

• 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: 16818031 BACKGROUND

• Palermo G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of single spermatozoon into an oocyte. Lancet. 1992 Jul 4;340(8810):17-8. doi: 10.1016/0140-6736(92)92425-f.

  PMID: 1351601 BACKGROUND

• Paynter SJ. Current status of the cryopreservation of human unfertilized oocytes. Hum Reprod Update. 2000 Sep-Oct;6(5):449-56. doi: 10.1093/humupd/6.5.449.

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• 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: 16735826 BACKGROUND

• Tucker M, Wright G, Morton P, Shanguo L, Massey J, Kort H. Preliminary experience with human oocyte cryopreservation using 1,2-propanediol and sucrose. Hum Reprod. 1996 Jul;11(7):1513-5. doi: 10.1093/oxfordjournals.humrep.a019428.

  PMID: 8671495 BACKGROUND

• Wolf DP (1991) ProH2 freeze/thaw protocol for human embryos IN OHSU procedure manual.

  BACKGROUND

• Wu J, Zhang L, Wang X. In vitro maturation, fertilization and embryo development after ultrarapid freezing of immature human oocytes. Reproduction. 2001 Mar;121(3):389-93. doi: 10.1530/rep.0.1210389.

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• 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: 12798878 BACKGROUND

• Yoon TK, Chung HM, Lim JM, Han SY, Ko JJ, Cha KY. Pregnancy and delivery of healthy infants developed from vitrified oocytes in a stimulated in vitro fertilization-embryo transfer program. Fertil Steril. 2000 Jul;74(1):180-1. doi: 10.1016/s0015-0282(00)00572-0. No abstract available.

  PMID: 10899519 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Avner Hershlag, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Matthew Cohen, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Huai L Feng, PhD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: October 1, 2012
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

US (1)