The main embryotoxicity quality controls are the mouse embryo test (MEA = Mouse Embryo Assay) and the human sperm survival test (HSSA = Human Sperm Survival Assay). The HSSA test measures the survival (or mobility) of human sperm after exposure to the tested consumable for a predetermined period of time and compares it to that of unexposed sperm. It would appear that the HSSA is comparable in terms of sensitivity to the MEA test for the detection of toxicity.
The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.
Study Type
OBSERVATIONAL
Enrollment
1,800
Human Sperm Survival Assay testing performed on different batches of different types of IVF consumables. In practice, 3 consumables from the same batch will be tested with 3 different sperms to ensure the repeatability of the result / test.
Private Hospital of Parly II-Le Chesnay
Le Chesnay, France
RECRUITINGPresence of embryotoxicity
Presence of embryotoxicity, defined by a mobility index relative to the control (SMI) \<0.85 observed on at least 2 of the three tests carried out on consumables from the same batch (isolated embryotoxicity).
Time frame: 1 day
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