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2009-10-02
Thorough quality testing of products important for IVF outcome |
| Success rates in assisted reproduction depend a lot on the quality of the products used. A recent study shows that not all utensils on the market fulfil the quality standards needed for safe procedures. |
Reprotoxicity can result in reduced implantation |
Contact materials used in ART-procedures can release specific molecules and components that can be toxic to human reproductive cells. This needs to be detected before introduction of the materials in the lab, as reprotoxicity can lead to immediate degeneration of embryos, or could have a clear negative impact on the fertilisation process and in vitro development of the reproductive and embryonic cells.
Reprotoxicity can also have a delayed manifestation, which could result in reduced implantation or ongoing pregnancy rates.1
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Results from a 4-year survey on reprotoxicity |
Genk Institute for Fertility Technology in Belgium recently presented a study in which they tested the suitability for products being implemented in ART-procedures. The group implemented the human sperm survival test (SpST) 2 as a routine QC bioassay for all new media, materials, disposables or products. Sperm survival after 24 and 96 hours was evaluated and compared to the control. The SpST was also used on all new batches to be used for different ART procedures.
Between November 2003- December 2007, 36 types of products from 72 companies were analysed in 350 SpST. In total, 13 products used in patient-, gamete-, and embryo-related ART-procedures were found to be reprotoxic.1
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In the study mentioned above all products from Vitrolife passed the SpST. Vitrolife was also the only supplier who had done a mouse embryo assay or a limulus gameteocyte lysate endotoxin test on products used in patient-related procedures.1
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Rinsing can improve results |
Rinsing of contact material before IVF procedures is very important, as debris left from the manufacturing process of plastics may affect the embryo development. To confirm that rinsing of dishes improves embryo viability, mouse embryos were cultured from zygote stage to blastocyst stage in rinsed and non rinsed dishes and blastocyst cell numbers were counted, see pictures.
The total cell number in blastocysts cultured in rinsed dishes was significantly higher than that of blastocysts cultured in non-rinsed dishes. 3
Read more about how to rinse with G-RINSE |
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 G-RINSE™
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Vitrolife has outstanding Quality Control |
Quality has always been, and still is a cornerstone in all our work. All our products and raw materials undergo strict quality control, including 1-cell mouse embryo assay, to ensure that we deliver products that can meet the high demands from our customers. During manufacturing there are process controls at all critical steps, to ensure that the products are within the specifications.
Before releasing products for sale, we test functionality as well as other quality aspects. Some of the tests below are specific for embryo culture products, other for instruments.
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| Functional tests
Mouse Embryo Assay (MEA)
Cumulus Cell Assay
Embryo Transfer Assay
Microdrop Assay
Human Sperm Assays
Biological tests
Bacterial endotoxin assay
Sterility
Bioburden Visual tests
Microscopical inspection
Package integrity
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| Physiochemical tests
pH
Osmolality
Viscosity
Density
Visual tests
Microscopical inspection
Package integrity
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1. Nijs et al. Fertil Steril. 2009 Aug; 92(2): 527-535
2. Critchlow et al. Hum Reprod 1989;4:545-9.
3. Data on file. 2006. Fertility Labs Colorado, Englewood, Colorado
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