Vitrification Versus Spontaneous Conception and Slow- Rate Freezing

Pregnancy Clinical Trial

Official title:

Maternal Pregnancy and Neonatal Outcome After Assisted Reproduction. Comparison of Vitrification vs. Spontaneous Conception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088425
• Other study ID #: UKSH-HL-09-195
• Secondary ID: 09-195
• Status: Completed
• Phase: N/A
• First received: March 16, 2010
• Last updated: March 12, 2017
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Observation
Alberta infant motor scale Griffiths test Kauffmann ABC

Locations

Country	Name	City	State
Germany	Schleswig- Holstein University, Campus Lübeck, Department of Reproductive Medicine	Lübeck	Schleswig- Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wennerholm UB, Söderström-Anttila V, Bergh C, Aittomäki 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal pregancy outcome	spontaneous or operative delivery, birth injuries, conjoined morbidity	7 years
Primary	embryo survival	embryo survival rate	7 years
Secondary	infant health	infant vital characteristics (APGAR, arterial cord ph), infant development: only develomental milestones: sitting, standing, walking infant morbidity	7 years