Clinical trial NCT01088425: Vitrification Versus Spontaneous Conception and Slow- Rate Freezing
Official title: Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 850
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary university hospital

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.


Eligibility 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

Primary outcomes:
measure: Maternal pregancy outcome
timeFrame: 7 years
measure: embryo survival
timeFrame: 7 years
Secondary outcomes:
measure: infant health
timeFrame: 7 years
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine
state: Schleswig- Holstein
Study officials:
affiliation: Lübeck University
name: Daniel A Beyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.