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InfertilityNCT00886431

Vitrification Versus Slow Cooling of Human Cleavage Stage Embryos

A study testing embryo vitrification in people with Infertility, run by UMC Utrecht at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Human embryos can be preserved for later transfers by freezing. Traditionally the slow cooling method has been used. About 70% of the embryos remain fully intact after thawing. However, the remaining 30% of the embryos become (partially) damaged, and this freezing damage reduces their chance to implant. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
embryo vitrification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
2 sitesin 2 countries
Study dates
May 2009to May 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • female patient age 35 years or less
  • embryos are obtained by in vitro fertilization (IVF) or intra cytoplasmatic spermatozoon injection (ICSI)
  • single embryo transfer
  • 1rst IVF/ICSI treatment with an embryo transfer
  • availability of cryopreservable embryos

Who cannot join

  • female patient age is 36 years or older
  • participants of oocyte donation program
  • participants of percutaneous spermatozoon aspiration (PESA) program
  • couples with a finite source of spermatozoa
  • absence of cryopreservable embryos

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Academic Hospital of Brussels

    Brussels, 1090

Other trials in Belgium

Netherlands1 site

  • University Medical Center of Utrecht

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: A Double Blinded, Randomised Controlled Trial Comparing the Effectiveness of Vitrification to Slow Cooling in Cryopreserving Human Preimplantation Embryos

Human embryos can be preserved for later transfers by freezing. Traditionally the slow cooling method has been used. About 70% of the embryos remain fully intact after thawing. However, the remaining 30% of the embryos become (partially) damaged, and this freezing damage reduces their chance to implant. Recently an ultra rapid freezing method, called vitrification has been developed. During vitrification no damaging ice crystals are formed and the embryo freezes in a glass like state.

It appears that the freezing damage is reduced when embryos are vitrified. Observational studies in humans indicate that embryos are successfully preserved by vitrification, as indicated by promising pregnancy rates following thawing. However, the effectiveness of vitrification in relation to slow cooling with respect to pregnancy rates has so far not been evaluated by a randomised, controlled trial. The aim of this study is to investigate whether vitrification significantly improves embryo survival and ongoing pregnancy rates when compared to embryos frozen by slow cooling.

Read the detailed description

time of allocation: following embryo selection

type of embryos: cleavage stage -, morula stage or early blastocyst stage embryo (day3 - day4 after oocyte collection)

cryoprotectants: sucrose, dimethylsulfoxide, ethyleneglycol

vitrification storage device: high security vitrification straws

Conditions
Infertility
Being tested
embryo vitrification
Keywords
IVF, embryo cryopreservation, vitrification, slow cooling, slow freezing, surplus embryos, Human Reproduction
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • embryo vitrificationOther

    Also called vitrification, high security vitrification straws

    Ultra rapid cooling of embryos by immersion in liquid nitrogen. The formation of potentially damaging ice crystals is prevented by briefly incubating the embryos in high concentrations of a mix of cryoprotectants.

Study groups in NCT00886431
Study groupRoleWhat they receive
VitrificationExperimentalThe embryos of patients allocated to this arm will be cryopreserved by vitrification.
Receives: Other: embryo vitrification
Slow coolingNo interventionThe embryos of patients allocated to this arm will be cryopreserved by the slow cooling method, which is the standard method (=no intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percent change of the ongoing pregnancy rate per patient/couple who use their thawed embryos (following a fesh embryo transfer which did not result in an ongoing pregnancy) from baseline (slow cooling) to end point (vitrification).

    Measured: ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo

Secondary outcomes (11)

  1. post-thaw embryo survival rate

    Measured: 1 hour after thawing

  2. ongoing pregnancy rate per patient using their thawed embryos (independent of whether they became pregnant following a fresh embryo transfer or not

    Measured: 10 weeks following transfer of frozen thawed embryo

  3. implantation rate per thawed embryo

    Measured: 10 weeks after transfer of thawed embryo

  4. implantation rate per transferred thawed embryo

    Measured: 10 weeks after transfer of thawed embryo

  5. cumulative implantation rate per cryopreservation

    Measured: 10 weeks after thawed embryo transfer

  6. ongoing pregnancy rate per frozen-thaw cycle

    Measured: 10 weeks following thawed embryo transfer

  7. average number of frozen-thawed cycles per patient

    Measured: is variable

  8. post thaw development (categorial) per thawed embryo

    Measured: 24 hours following thawing

  9. average number of cryo-thaw cycles to ongoing pregnancy

    Measured: variable, up to 3 years

  10. average number of thawed embryos to ongoing implantation

    Measured: variable, up to 3 years

  11. Life birth rate

    Measured: 9 month after pregnancy test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00886431
Sponsor's protocol ID
Vitrification study
Other IDs
CCMO NL23499.000.08, METC 08/183
Status last verified
Nov 2014
First submitted
22 Apr 2009
Last updated
2 Dec 2014
Results posted
No
Data monitoring committee
No

Publications

  • Boonkusol D, Gal AB, Bodo S, Gorhony B, Kitiyanant Y, Dinnyes A. Gene expression profiles and in vitro development following vitrification of pronuclear and 8-cell stage mouse embryos. Mol Reprod Dev. 2006 Jun;73(6):700-8. doi: 10.1002/mrd.20450.

    PubMed 16541460

  • Burns WN, Gaudet TW, Martin MB, Leal YR, Schoen H, Eddy CA, Schenken RS. Survival of cryopreservation and thawing with all blastomeres intact identifies multicell embryos with superior frozen embryo transfer outcome. Fertil Steril. 1999 Sep;72(3):527-32. doi: 10.1016/s0015-0282(99)00280-0.

    PubMed 10519629

  • 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.

    PubMed 17298725

  • Edgar DH, Bourne H, Speirs AL, McBain JC. A quantitative analysis of the impact of cryopreservation on the implantation potential of human early cleavage stage embryos. Hum Reprod. 2000 Jan;15(1):175-9. doi: 10.1093/humrep/15.1.175.

    PubMed 10611209

  • 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.

    PubMed 15333245

  • Mukaida T, Nakamura S, Tomiyama T, Wada S, Kasai M, Takahashi K. Successful birth after transfer of vitrified human blastocysts with use of a cryoloop containerless technique. Fertil Steril. 2001 Sep;76(3):618-20. doi: 10.1016/s0015-0282(01)01968-9.

    PubMed 11532492

  • 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.

    PubMed 16274602

  • Salumets A, Suikkari AM, Makinen S, Karro H, Roos A, Tuuri T. Frozen embryo transfers: implications of clinical and embryological factors on the pregnancy outcome. Hum Reprod. 2006 Sep;21(9):2368-74. doi: 10.1093/humrep/del151. Epub 2006 May 9.

    PubMed 16684837

  • Sheehan CB, Lane M, Gardner DK. The CryoLoop facilitates re-vitrification of embryos at four successive stages of development without impairing embryo growth. Hum Reprod. 2006 Nov;21(11):2978-84. doi: 10.1093/humrep/del253. Epub 2006 Sep 1.

    PubMed 16950825

  • 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.

    PubMed 16102287

  • 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.

    PubMed 16009162

  • 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.

    PubMed 17359578

  • 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.

    PubMed 16762345

  • Yokota Y, Sato S, Yokota M, Yokota H, Araki Y. Birth of a healthy baby following vitrification of human blastocysts. Fertil Steril. 2001 May;75(5):1027-9. doi: 10.1016/s0015-0282(01)01685-5.

    PubMed 11334922

Questions about this trial

What is this clinical trial studying?

A study testing embryo vitrification in people with Infertility, run by UMC Utrecht at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percent change of the ongoing pregnancy rate per patient/couple who use their thawed embryos (following a fesh embryo transfer which did not result in an ongoing pregnancy) from baseline (slow cooling) to end point (vitrification). (time frame: ongoing pregnancy is established 10 weeks following the transfer of a frozen embryo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00886431, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.

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