Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

NCT01088425 | Completed DMC

• 2 other identifiers: UKSH-HL-09-19509-195
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Maternal pregancy outcome

  spontaneous or operative delivery, birth injuries, conjoined morbidity

  7 years

• embryo survival

  embryo survival rate

  7 years

Secondary Outcomes (1)

• infant health

  7 years

Study Arms (3)

Spontaneous

Mothers with children conceived after spontaneous cycle

Other: Observation

Vitrificatíon

Mothers with children conceived after vitrification cycle

Other: Observation

slow- rate freezing

Mothers with children conceived after slow- rate freezing cycle

Other: Observation

Interventions

Observation OTHER

Alberta infant motor scale Griffiths test Kauffmann ABC

Spontaneous; Vitrificatíon; slow- rate freezing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

tertiary university hospital

You may qualify if:

• cryopreservation (vitrification and slow- rate freezing) between 1998 - 2010
• Treatment in Lübeck University
• Delivery in Lübeck University
• Positive informed consent

You may not qualify if:

• Negative informed consent

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

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

Lübeck, Schleswig-Holstein, D-23538, Germany

Location

Related Publications (6)

• 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.

  PMID: 19458318 BACKGROUND

• 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.

  PMID: 17579980 BACKGROUND

• 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.

  PMID: 19490780 BACKGROUND

• 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.

  PMID: 20188356 BACKGROUND

• 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.

  PMID: 20185513 BACKGROUND

• 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.

  PMID: 17359578 BACKGROUND

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Daniel A Beyer, MD

  Lübeck University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. D. A. Beyer

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 17, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

DE (1)