Oocyte Cryopreservation

NCT01232972 | Terminated

• 1 other identifier: 10-203A
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this investigation is to offer the opportunity for young women to cryopreserve (freeze) their oocytes (eggs) for use with IVF at a later point in time.

Conditions

Fertility

Keywords

vitrification; egg freezing; oocyte cryopreservation; female fertility potential; fertility preservation; Fertility preservation, female

Outcome Measures

Primary Outcomes (1)

• Successful pregnancy

  Eggs will be frozen via vitrification for those females electing to preserve their fertility; patients will return following an unspecified time period, when they are ready to use their frozen eggs. At that time, the eggs will be thawed and fertilized (with the sperm source of the participant's choice) to create embryos. This time frame will be unique to each individual; however, the Center has a policy whereby no embryo transfer will be performed beyond the age of fifty (50).

  until the patient reaches 50 years of age

Secondary Outcomes (4)

• oocyte survival

  up to 50 years of age

• fertilization

  up to 50 years of age

• blastocyst formation

  up to 50 years of age

• implantation

  up to 50 years of age

Study Arms (1)

oocyte freezing

EXPERIMENTAL

includes any women who elects to preserve her fertility by vitrifying her unfertilized eggs.

Procedure: vitrification of oocytes

Interventions

vitrification of oocytes PROCEDURE

eggs will be preserved via vitrification the day they are retrieved from the participant

oocyte freezing

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• women between the ages of 18 and 42
• election to preserve fertility by freezing eggs

You may not qualify if:

• women over the age of 43
• patient unwilling to sign informed consent

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Center for Human Reproduction

Manhasset, New York, 11030, United States

Location

Related Publications (13)

• Ethics Committee of the American Society for Reproductive Medicine. Fertility preservation and reproduction in cancer patients. Fertil Steril. 2005 Jun;83(6):1622-8. doi: 10.1016/j.fertnstert.2005.03.013.

  PMID: 15950628 BACKGROUND

• 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: 17846105 BACKGROUND

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

  PMID: 17008147 BACKGROUND

• Nagy ZP, Chang CC, Shapiro DB, Bernal DP, Kort HI, Vajta G. The efficacy and safety of human oocyte vitrification. Semin Reprod Med. 2009 Nov;27(6):450-5. doi: 10.1055/s-0029-1241054. Epub 2009 Oct 5.

  PMID: 19806513 BACKGROUND

• Kuwayama M, Vajta G, Kato O, Leibo SP. Highly efficient vitrification method for cryopreservation of human oocytes. Reprod Biomed Online. 2005 Sep;11(3):300-8. doi: 10.1016/s1472-6483(10)60837-1.

  PMID: 16176668 BACKGROUND

• Lee SJ, Schover LR, Partridge AH, Patrizio P, Wallace WH, Hagerty K, Beck LN, Brennan LV, Oktay K; American Society of Clinical Oncology. American Society of Clinical Oncology recommendations on fertility preservation in cancer patients. J Clin Oncol. 2006 Jun 20;24(18):2917-31. doi: 10.1200/JCO.2006.06.5888. Epub 2006 May 1.

  PMID: 16651642 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

• Noyes N, Boldt J, Nagy ZP. Oocyte cryopreservation: is it time to remove its experimental label? J Assist Reprod Genet. 2010 Feb;27(2-3):69-74. doi: 10.1007/s10815-009-9382-y. Epub 2010 Feb 6.

  PMID: 20140641 BACKGROUND

• 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

• Nagy ZP, Diaz DG, Diaz R, Bennett A, Al-Sabagh R, V Maamari. Human oocyte preservation (Hope): preliminary results. Fertil Steril 92, Supp3:S189, 2009

  BACKGROUND

• Nagy ZP, Chang CC, Bernal DP, Shapiro D, Mitchell-Leef D and Kort HI. Comparison of laboratory and clinical outcomes between fresh and vitrified sibling oocytes obtained from 30-39 year old IVF patients. Fertil Steril 92,Supp3:S67, 2009.

  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

• Practice Committees of the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology. Mature oocyte cryopreservation: a guideline. Fertil Steril. 2013 Jan;99(1):37-43. doi: 10.1016/j.fertnstert.2012.09.028. Epub 2012 Oct 22.

  PMID: 23083924 BACKGROUND

Study Officials

• Avner Hershlag, MD

  Center for Human Reproduction

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)