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Completed

NCT Number: NCT01088425

Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

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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Key information

Conditions

Pregnancy

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lübeck, Schleswig-Holstein, D-23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Alberta infant motor scale

Griffiths test

Kauffmann ABC

Primary outcomes

  1. Maternal pregancy outcome

    Time frame: 7 years

    spontaneous or operative delivery, birth injuries, conjoined morbidity

  2. embryo survival

    Time frame: 7 years

    embryo survival rate

Secondary outcomes

  1. infant health

    Time frame: 7 years

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

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Official study title

Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2010
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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