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Embryotoxicity testing of IVF disposables: how do manufacturers test?
L Delaroche1,2, P Oger1, E Genauzeau1,2
1Centre d'AMP, Ramsay Santé, Hôpital Privé de Parly 2, 21 rue Moxouris, 78150 Le Chesnay, France.
Human Reproduction (Oxford, England)
|February 14, 2020
Summary
Manufacturers use varied methods for embryotoxicity testing of IVF disposables, impacting test sensitivity. Standardization and transparency in Mouse Embryo Assay (MEA) and Human Sperm Survival Assay (HSSA) are needed for reliable IVF consumable validation.
Area of Science:
- Reproductive Biology
- In Vitro Fertilization (IVF)
- Toxicology
Background:
- IVF consumables and media can negatively affect human embryonic development.
- Quality control for IVF disposables is crucial for successful ART procedures.
Purpose of the Study:
- To compare the methodologies of the Mouse Embryo Assay (MEA) and Human Sperm Survival Assay (HSSA) used by IVF disposable manufacturers.
- To assess the heterogeneity in embryotoxicity testing protocols for IVF consumables.
Main Methods:
- A questionnaire survey was distributed to major IVF disposable manufacturers.
- Methodologies for MEA and HSSA, including parameters like embryo strain, culture conditions, and thresholds, were collected and compared.
Main Results:
- Only 11 out of 21 approached manufacturers responded.
- Significant differences were found in the MEA and HSSA methodologies and thresholds used by different companies.
- These variations can influence the sensitivity and reliability of the toxicity tests.
Conclusions:
- There is a high degree of heterogeneity in embryotoxicity testing for IVF disposables among manufacturers.
- Lack of standardization and transparency in testing protocols is a concern.
- There is an urgent need for standardized, transparent, and reproducible embryotoxicity assays in the IVF industry.

