Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

Completed

• Conditions: Pregnancy
• Interventions: Other: Observation

• Registration Number: NCT01088425
• Lead Sponsor: University of Luebeck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-12
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spontaneous	Observation	Mothers with children conceived after spontaneous cycle
Vitrificatíon	Observation	Mothers with children conceived after vitrification cycle
slow- rate freezing	Observation	Mothers with children conceived after slow- rate freezing cycle

Primary Outcome Measures

Name	Time	Method
Maternal pregancy outcome	7 years	spontaneous or operative delivery, birth injuries, conjoined morbidity
embryo survival	7 years	embryo survival rate

Secondary Outcome Measures

Name	Time	Method
infant health	7 years	infant vital characteristics (APGAR, arterial cord ph), infant development: only develomental milestones: sitting, standing, walking infant morbidity

Trial Locations

Locations (1)

Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine; 🇩🇪 Lübeck, Schleswig- Holstein, Germany