Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

NCT ID: NCT01088425

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Spontaneous

Mothers with children conceived after spontaneous cycle

Observation

Intervention Type OTHER

Alberta infant motor scale

Griffiths test

Kauffmann ABC

Vitrificatíon

Mothers with children conceived after vitrification cycle

Observation

Intervention Type OTHER

Alberta infant motor scale

Griffiths test

Kauffmann ABC

slow- rate freezing

Mothers with children conceived after slow- rate freezing cycle

Observation

Intervention Type OTHER

Alberta infant motor scale

Griffiths test

Kauffmann ABC

Interventions

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Observation

Alberta infant motor scale

Griffiths test

Kauffmann ABC

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Daniel Alexander Beyer

Dr. D. A. Beyer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel A Beyer, MD

Role: PRINCIPAL_INVESTIGATOR

Lübeck University

Locations

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Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 19458318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17579980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19490780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20188356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20185513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17359578 (View on PubMed)

Other Identifiers

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09-195

Identifier Type: REGISTRY

Identifier Source: secondary_id

UKSH-HL-09-195

Identifier Type: -

Identifier Source: org_study_id

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