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Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Daniel Alexander Beyer, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01088425
First received: March 16, 2010
Last updated: June 5, 2014
Last verified: June 2014
  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
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine
Lübeck, Schleswig- Holstein, Germany, D-23538
Sponsors and Collaborators
University of Luebeck
Investigators
Principal Investigator: Daniel A Beyer, MD Lübeck University
  More Information

Publications:

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: June 5, 2014
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 November 27, 2014