A Comparison of Two Freezing Techniques

Infertility Clinical Trial

Official title:

A Comparison of Two Freezing Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852306
• Other study ID #: 08-265
• Status: Completed
• Phase: N/A
• First received: February 25, 2009
• Last updated: October 8, 2012
• Start date: February 2009
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• 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 study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.

Description:

Human egg freezing is rapidly becoming a vital tool in Assisted Reproductive Technology. Candidates for egg freezing include women without partners who wish to preserve their fertility; cancer patients at risk of losing fertility from chemotherapy; and donor egg recipients. While in the past, egg freezing has not been as successful as embryo freezing in producing live births, recent experience in several centers has demonstrated significant improvement, with pregnancy rates comparable to those achieved with frozen embryos. The purpose of this study is to determine the best method to freeze eggs. We shall be seeking volunteers from the egg donor program, since young, fertile donors represent the best model to study the effect of egg freezing.

We plan to enroll 12 recipients and 6 donors in this study. Each egg donor will go through a stringent screening process (medical, genetic and psychological). Eggs retrieved from all donors will be split in half: one half will be frozen by the slow freeze method, and the other half by vitrification. Each of the six donors will be paired with two recipients; each recipient will be assigned half the total eggs frozen. For each recipient, half of the eggs will come from the slow freeze group and the other half will come from vitrification.

When the recipient's uterine lining is deemed ready (following estrogen treatment and ultrasound monitoring), thawing will be performed on eggs frozen by either the slow freeze or the vitrification method. The thaw process will be randomized between the two types of freezing. One sperm will be injected into each egg that survived the freeze. Fertilization and embryo development will be recorded. Ideally, two embryos will be transferred into the recipient's uterus. Pregnancy will be determined by a blood test and followed by serial blood tests and ultrasound.

The study will determine which freezing method yields better survival and pregnancy rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• oocyte freezing
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.

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	EMD Serono

Country where clinical trial is conducted

United States, 

References & Publications (21)

Cohen J, Alikani M, Trowbridge J, Rosenwaks Z. Implantation enhancement by selective assisted hatching using zona drilling of human embryos with poor prognosis. Hum Reprod. 1992 May;7(5):685-91. — View Citation

Diaz DG, Rodriguez-Karl MC and Moody JE (2007) Human oocyte cryopreservation: preliminary results of survival, fertilization and cleavage rate of frozen oocyte using a new modified slow-freeze protocol. Fertil Steril 88, Suppl 1:S47.

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

Fosas N, Marina F, Torres PJ, Jové I, Martín P, Pérez N, Arnedo N, Marina S. The births of five Spanish babies from cryopreserved donated oocytes. Hum Reprod. 2003 Jul;18(7):1417-21. — View Citation

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

Hershlag A, Paine T, Kvapil G, Feng H, Napolitano B. In vitro fertilization-intracytoplasmic sperm injection split: an insemination method to prevent fertilization failure. Fertil Steril. 2002 Feb;77(2):229-32. — View Citation

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

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

Kumayama M and Kato O (2000b) All-round vitrification method for human oocytes and embryos. J Asst Reprod Gen 17:447.

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.

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. — View Citation

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

Oktay K, Cil AP, Bang H. Efficiency of oocyte cryopreservation: a meta-analysis. Fertil Steril. 2006 Jul;86(1):70-80. — View Citation

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. — View Citation

Paynter SJ. Current status of the cryopreservation of human unfertilized oocytes. Hum Reprod Update. 2000 Sep-Oct;6(5):449-56. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of a pregnancy, as determined by a fetal heartbeat		2 months	No
Secondary	Percentage of eggs that result in blastocyst formation		1 week	No
Secondary	Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure)		2 days	No
Secondary	ICSI fertilization rate (percentage of eggs that fertilize)		2 days	No
Secondary	Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized)		2 days	No