Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

This study is currently recruiting participants.

Verified August 2011 by University of Luebeck

Sponsor:

Information provided by (Responsible Party):

Daniel Alexander Beyer, University of Luebeck

ClinicalTrials.gov Identifier:

NCT01088425

First received: March 16, 2010

Last updated: August 22, 2011

Last verified: August 2011

History of Changes

Purpose

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.

Condition	Intervention
Pregnancy	Other: Observation

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception

Further study details as provided by University of Luebeck:

Primary Outcome Measures:

Maternal pregancy outcome [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
spontaneous or operative delivery, birth injuries, conjoined morbidity
embryo survival [ Time Frame: 7 years ] [ Designated as safety issue: No ]
embryo survival rate

Secondary Outcome Measures:

infant health [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
infant vital characteristics (APGAR, arterial cord ph), infant development: only develomental milestones: sitting, standing, walking infant morbidity

Estimated Enrollment:	850
Study Start Date:	March 2010

Groups/Cohorts	Assigned Interventions
Spontaneous Mothers with children conceived after spontaneous cycle	Other: Observation Alberta infant motor scale Griffiths test Kauffmann ABC
Vitrificatíon Mothers with children conceived after vitrification cycle	Other: Observation Alberta infant motor scale Griffiths test Kauffmann ABC
slow- rate freezing Mothers with children conceived after slow- rate freezing cycle	Other: Observation Alberta infant motor scale Griffiths test Kauffmann ABC

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

tertiary university hospital

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Negative informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088425

Contacts

Contact: Daniel A Beyer, M.D.

+49 500 2141

daniel.beyer@uk-sh.de

Locations

Germany
Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine	Recruiting
Lübeck, Schleswig- Holstein, Germany, D-23538
Contact: Daniel A Beyer, M.D. + 49 451 500´2141 daniel.beyer@uk-sh.de
Principal Investigator: Daniel A Beyer, M.D.
Sub-Investigator: Julia Klett, MD

Sponsors and Collaborators

University of Luebeck

Investigators

Principal Investigator:

Daniel A Beyer, MD

Lübeck University

More Information

Publications:

Wennerholm UB, Söderström-Anttila V, Bergh C, Aittomäki 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. Epub 2009 May 20. Review.

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.

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.

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 Feb 24; [Epub ahead of print]

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 Feb 25; [Epub ahead of print]

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.

Responsible Party:	Daniel Alexander Beyer, Dr. D. A. Beyer, University of Luebeck
ClinicalTrials.gov Identifier:	NCT01088425 History of Changes
Other Study ID Numbers:	UKSH-HL-09-195, 09-195
Study First Received:	March 16, 2010
Last Updated:	August 22, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Luebeck:

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

ClinicalTrials.gov processed this record on June 18, 2013

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