Overview

This trial is active, not recruiting.

Condition pregnancy
Treatment observation
Sponsor University of Luebeck
Start date March 2010
End date December 2016
Trial size 850 participants
Trial identifier NCT01088425, 09-195, UKSH-HL-09-195

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
Mothers with children conceived after spontaneous cycle
observation
Alberta infant motor scale Griffiths test Kauffmann ABC
Mothers with children conceived after vitrification cycle
observation
Alberta infant motor scale Griffiths test Kauffmann ABC
Mothers with children conceived after slow- rate freezing cycle
observation
Alberta infant motor scale Griffiths test Kauffmann ABC

Primary Outcomes

Measure
Maternal pregancy outcome
time frame: 7 years
embryo survival
time frame: 7 years

Secondary Outcomes

Measure
infant health
time frame: 7 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception
Principal investigator Daniel A Beyer, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Luebeck.