Comparison Between Three Freezing Protocols to Preserve Human Embryos

NCT00910390 | Completed

• 1 other identifier: VITR-1-EMBRYOS
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized study compares three different freezing methods to store human in vitro fertilization (IVF) embryos: vitrification with two commercial kits or slow freezing. After information, all patients undergoing IVF treatment can be included in the study. If qualified, embryos at different developmental stages will be allocated between the three methods. At the end of the first year survival and developmental rates, and implantation and pregnancy rates will be analyzed in order to determine the best method.

Conditions

Human Embryo Cryopreservation

Keywords

IVF; embryo cryopreservation; vitrification; Human Embryo; Embryonic development; Pregnancy rate

Outcome Measures

Primary Outcomes (1)

• Survival embryo rate

  one year

Secondary Outcomes (1)

• Delivery rate

  one year

Study Arms (3)

Slow Freezing

PLACEBO COMPARATOR

Standard freezing protocol (slow freezing) of preimplantation embryos

Other: Slow freezing

VIT-Irvine

EXPERIMENTAL

Vitrification with Irvine solution (rapid freezing) of preimplantation embryos

Other: VIT-Irvine

VIT-Vitrolife

EXPERIMENTAL

Vitrification (rapid freezing) with Vitrolife solution

Other: Vit-Vitrolife

Interventions

Slow freezing OTHER

Embryos at different developmental stages will be frozen using a solution that contains propanediol and sucrose, individually placed in high security straws, cooled with a programmator and stored in liquid nitrogen.

Also known as: Home-made solutions, propanediol

Slow Freezing

VIT-Irvine OTHER

Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.

Also known as: IRVINE, California, ethylene glycol, DMSO

VIT-Irvine

Vit-Vitrolife OTHER

Embryos at different developmental stages will be frozen using the vitrification solution according to the manufacturer's instructions, individually placed in high security vitrification devices and plunged directly in liquid nitrogen for storing.

Also known as: VITROLIFE, Sweden, ethylene glycol, propanediol

VIT-Vitrolife

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertility requiring IVF

You may not qualify if:

• Women's age \> 43 years
• Patients positive for hepatitis B or C
• Patients positive for HIV

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

IVF laboratory, Hospital Erasme, Route de Lennik 808

Brussels, 1070, Belgium

Location

Related Publications (19)

• Al-Hasani S, Ozmen B, Koutlaki N, Schoepper B, Diedrich K, Schultze-Mosgau A. Three years of routine vitrification of human zygotes: is it still fair to advocate slow-rate freezing? Reprod Biomed Online. 2007 Mar;14(3):288-93. doi: 10.1016/s1472-6483(10)60869-3.

  PMID: 17359578 BACKGROUND

• Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.

  PMID: 18544577 BACKGROUND

• Desai N, Blackmon H, Szeptycki J, Goldfarb J. Cryoloop vitrification of human day 3 cleavage-stage embryos: post-vitrification development, pregnancy outcomes and live births. Reprod Biomed Online. 2007 Feb;14(2):208-13. doi: 10.1016/s1472-6483(10)60789-4.

  PMID: 17298725 BACKGROUND

• Escriba MJ, Zulategui JF, Galan A, Mercader A, Remohi J, de los Santos MJ. Vitrification of preimplantation genetically diagnosed human blastocysts and its contribution to the cumulative ongoing pregnancy rate per cycle by using a closed device. Fertil Steril. 2008 Apr;89(4):840-6. doi: 10.1016/j.fertnstert.2007.04.035. Epub 2007 Aug 6.

  PMID: 17681342 BACKGROUND

• Huang CC, Lee TH, Chen SU, Chen HH, Cheng TC, Liu CH, Yang YS, Lee MS. Successful pregnancy following blastocyst cryopreservation using super-cooling ultra-rapid vitrification. Hum Reprod. 2005 Jan;20(1):122-8. doi: 10.1093/humrep/deh540. Epub 2004 Oct 7.

  PMID: 15471932 BACKGROUND

• Kasai M, Mukaida T. Cryopreservation of animal and human embryos by vitrification. Reprod Biomed Online. 2004 Aug;9(2):164-70. doi: 10.1016/s1472-6483(10)62125-6.

  PMID: 15333245 BACKGROUND

• Kattera S, Chen C. Cryopreservation of embryos by vitrification: current development. Int Surg. 2006 Sep-Oct;91(5 Suppl):S55-62.

  PMID: 17436605 BACKGROUND

• Kuwayama M, Vajta G, Ieda S, Kato O. Comparison of open and closed methods for vitrification of human embryos and the elimination of potential contamination. Reprod Biomed Online. 2005 Nov;11(5):608-14. doi: 10.1016/s1472-6483(10)61169-8.

  PMID: 16409712 BACKGROUND

• Kuwayama M. Highly efficient vitrification for cryopreservation of human oocytes and embryos: the Cryotop method. Theriogenology. 2007 Jan 1;67(1):73-80. doi: 10.1016/j.theriogenology.2006.09.014. Epub 2006 Oct 20.

  PMID: 17055564 BACKGROUND

• Liebermann J, Nawroth F, Isachenko V, Isachenko E, Rahimi G, Tucker MJ. Potential importance of vitrification in reproductive medicine. Biol Reprod. 2002 Dec;67(6):1671-80. doi: 10.1095/biolreprod.102.006833.

  PMID: 12444040 BACKGROUND

• Liebermann J, Dietl J, Vanderzwalmen P, Tucker MJ. Recent developments in human oocyte, embryo and blastocyst vitrification: where are we now? Reprod Biomed Online. 2003 Dec;7(6):623-33. doi: 10.1016/s1472-6483(10)62084-6.

  PMID: 14748959 BACKGROUND

• Liebermann J, Tucker MJ. Comparison of vitrification and conventional cryopreservation of day 5 and day 6 blastocysts during clinical application. Fertil Steril. 2006 Jul;86(1):20-6. doi: 10.1016/j.fertnstert.2006.01.029. Epub 2006 Jun 8.

  PMID: 16762345 BACKGROUND

• Loutradi KE, Kolibianakis EM, Venetis CA, Papanikolaou EG, Pados G, Bontis I, Tarlatzis BC. Cryopreservation of human embryos by vitrification or slow freezing: a systematic review and meta-analysis. Fertil Steril. 2008 Jul;90(1):186-93. doi: 10.1016/j.fertnstert.2007.06.010. Epub 2007 Nov 5.

  PMID: 17980870 BACKGROUND

• Nawroth F, Rahimi G, Isachenko E, Isachenko V, Liebermann M, Tucker MJ, Liebermann J. Cryopreservation in assisted reproductive technology: new trends. Semin Reprod Med. 2005 Nov;23(4):325-35. doi: 10.1055/s-2005-923390.

  PMID: 16317621 BACKGROUND

• Rama Raju GA, Haranath GB, Krishna KM, Prakash GJ, Madan K. Vitrification of human 8-cell embryos, a modified protocol for better pregnancy rates. Reprod Biomed Online. 2005 Oct;11(4):434-7. doi: 10.1016/s1472-6483(10)61135-2.

  PMID: 16274602 BACKGROUND

• Stehlik E, Stehlik J, Katayama KP, Kuwayama M, Jambor V, Brohammer R, Kato O. Vitrification demonstrates significant improvement versus slow freezing of human blastocysts. Reprod Biomed Online. 2005 Jul;11(1):53-7. doi: 10.1016/s1472-6483(10)61298-9.

  PMID: 16102287 BACKGROUND

• Takahashi K, Mukaida T, Goto T, Oka C. Perinatal outcome of blastocyst transfer with vitrification using cryoloop: a 4-year follow-up study. Fertil Steril. 2005 Jul;84(1):88-92. doi: 10.1016/j.fertnstert.2004.12.051.

  PMID: 16009162 BACKGROUND

• Vajta G, Nagy ZP. Are programmable freezers still needed in the embryo laboratory? Review on vitrification. Reprod Biomed Online. 2006 Jun;12(6):779-96. doi: 10.1016/s1472-6483(10)61091-7.

  PMID: 16792858 BACKGROUND

• Youssry M, Ozmen B, Zohni K, Diedrich K, Al-Hasani S. Current aspects of blastocyst cryopreservation. Reprod Biomed Online. 2008 Feb;16(2):311-20. doi: 10.1016/s1472-6483(10)60591-3.

  PMID: 18284893 BACKGROUND

MeSH Terms

Interventions

Propylene Glycol; Ethylene Glycol; Dimethyl Sulfoxide

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Ethylene Glycols; Sulfoxides; Sulfur Compounds

Study Officials

• Anne Delbaere, Ph.D.

  Fertility Clinic, Hospital Erasme

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Embryologist

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: May 1, 2011
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)