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CompletedNCT01088425Updated Mar 14, 2017

Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

An observational study in Pregnancy, sponsored by University of Luebeck. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2017-03-14.

Sponsored by University of Luebeck · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
850
Sex
All
01

Study summary

Great scientific effort has been made to improve practical as well as economical procedures of modern assisted reproduction.

In the last years a shift from the well established method of slow-rate freezing to vitrification of 2PN zygotes and embryos could be observed. Like any other method of cryopreservation, the outcome of vitrification will be affected by several factors related to technique itself, its practical management and patient characteristics.

The investigators want to investigate the influence of vitrification on the outcome of of 2PN oocytes, pregnancy and infant health.

A Comparison between a cohort of spontaneous conceived children and children of vitrified and slow- cooled 2PN oocytes is planned.

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Conditions studied

  • Pregnancy

Keywords

  • vitrification
  • 2PN oocyte
  • maternal and infant health
  • embryo survival, clinical pregnancy rate
  • mode of delivery
  • injury during delivery
  • infant development
  • infant morbidity
  • slow- rate freezing
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In context

Lead sponsor

University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

tertiary university hospital

Inclusion criteria

  • cryopreservation (vitrification and slow- rate freezing) between 1998 - 2010
  • Treatment in Lübeck University
  • Delivery in Lübeck University
  • Positive informed consent

Exclusion criteria

Exclusion Criteria:

  • Negative informed consent
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
850 participants (estimated)

Groups and cohorts

  • Spontaneous

    Mothers with children conceived after spontaneous cycle

    Other: Observation

  • Vitrificatíon

    Mothers with children conceived after vitrification cycle

    Other: Observation

  • slow- rate freezing

    Mothers with children conceived after slow- rate freezing cycle

    Other: Observation

Interventions

  • OtherObservation

    Alberta infant motor scale Griffiths test Kauffmann ABC

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What researchers measure

Primary outcomes

  1. Maternal pregancy outcome

    spontaneous or operative delivery, birth injuries, conjoined morbidity

    Time frame: 7 years

  2. embryo survival

    embryo survival rate

    Time frame: 7 years

Secondary outcomes

  1. infant health

    infant vital characteristics (APGAR, arterial cord ph), infant development: only develomental milestones: sitting, standing, walking infant morbidity

    Time frame: 7 years

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Study locations

1 site
  • Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine
    Lübeck, Schleswig- Holstein D-23538, Germany
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References and documents

Publications

  • Wennerholm UB, Soderstrom-Anttila V, Bergh C, Aittomaki K, Hazekamp J, Nygren KG, Selbing A, Loft A. Children born after cryopreservation of embryos or oocytes: a systematic review of outcome data. Hum Reprod. 2009 Sep;24(9):2158-72. doi: 10.1093/humrep/dep125. Epub 2009 May 20. PubMed 19458318 ↗
  • Kagawa N, Kuwayama M, Nakata K, Vajta G, Silber S, Manabe N, Kato O. Production of the first offspring from oocytes derived from fresh and cryopreserved pre-antral follicles of adult mice. Reprod Biomed Online. 2007 Jun;14(6):693-9. doi: 10.1016/s1472-6483(10)60670-0. PubMed 17579980 ↗
  • Noyes N, Porcu E, Borini A. Over 900 oocyte cryopreservation babies born with no apparent increase in congenital anomalies. Reprod Biomed Online. 2009 Jun;18(6):769-76. doi: 10.1016/s1472-6483(10)60025-9. PubMed 19490780 ↗
  • Noyes N, Knopman J, Labella P, McCaffrey C, Clark-Williams M, Grifo J. Oocyte cryopreservation outcomes including pre-cryopreservation and post-thaw meiotic spindle evaluation following slow cooling and vitrification of human oocytes. Fertil Steril. 2010 Nov;94(6):2078-82. doi: 10.1016/j.fertnstert.2010.01.019. Epub 2010 Feb 26. PubMed 20188356 ↗
  • Ubaldi F, Anniballo R, Romano S, Baroni E, Albricci L, Colamaria S, Capalbo A, Sapienza F, Vajta G, Rienzi L. Cumulative ongoing pregnancy rate achieved with oocyte vitrification and cleavage stage transfer without embryo selection in a standard infertility program. Hum Reprod. 2010 May;25(5):1199-205. doi: 10.1093/humrep/deq046. Epub 2010 Feb 25. PubMed 20185513 ↗
  • 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01088425
Lead sponsor
University of Luebeck
Responsible party
Daniel Alexander Beyer (Dr. D. A. Beyer, University of Luebeck) — Principal investigator
First posted
Mar 17, 2010
Start date
Mar 2010
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Mar 14, 2017

Study contacts

Daniel A Beyer, MD
principal investigator · Lübeck University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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