Oocyte Cryopreservation

Fertility Clinical Trial

— egg freezing  

Official title:

Oocyte Cryopreservation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01232972
• Other study ID #: 10-203A
• Status: Terminated
• Phase: N/A
• First received: October 29, 2010
• Last updated: April 22, 2013
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• women between the ages of 18 and 42

• election to preserve fertility by freezing eggs

Exclusion Criteria:

• women over the age of 43

• patient unwilling to sign informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fertility

Intervention

Procedure:
• vitrification of oocytes
eggs will be preserved via vitrification the day they are retrieved from the participant

Locations

Country	Name	City	State
United States	Center for Human Reproduction	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Fioravanti J, Alegretti JR, Hassun PA, Motta ELA, Serafini PC and Smith GD. Prospective randomized comparison of human oocyte freezing and vitrification: an update. Fertil Steril 88, Suppl 1:S13, 2007.

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

Jain JK, Paulson RJ. Oocyte cryopreservation. Fertil Steril. 2006 Oct;86(4 Suppl):1037-46. Review. — View Citation

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. — View Citation

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. Epub 2006 May 1. Erratum in: J Clin Oncol. 2006 Dec 20;24(36):5790. — View Citation

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.

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. — View Citation

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. Review. — View Citation

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

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. Review. Erratum in: J Assist Reprod Genet. 2010 May;27(5):259. — View Citation

Porcu E, Venturoli S. Progress with oocyte cryopreservation. Curr Opin Obstet Gynecol. 2006 Jun;18(3):273-9. Review. — View Citation

Practice Committees of American Society for Reproductive Medicine; 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	oocyte survival	the number of eggs that successfully survive the frozen-thawing procedure (vitrification).	up to 50 years of age	No
Secondary	fertilization	to calculate the rate for the number of oocytes that are successfully fertilized (via ICSI) following survival of the frozen-thaw procedure.	up to 50 years of age	No
Secondary	blastocyst formation	calculates the number of successfully fertilized embryos that grow into blastocysts (day 5 of culture), created from eggs that underwent and survived vitrification.	up to 50 years of age	No
Secondary	implantation	to determine the implantation rate of embryos that were created from vitrified oocytes.	up to 50 years of age	No