Embryotoxicity, Human Sperm Survival Assay, in Vitro Fertilization
Conditions
Brief summary
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.
Detailed description
The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.
Interventions
BIOLOGICALHSSA test
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.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
European Clinical Trial Experts Network
Private hospital Parly II
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Inclusion criteria
* Male over 18 years-old * Normal spermogram (concentration ≥15 million / ml or total count\> 39 million, progressive mobility ≥32% or total mobility ≥40%) * Progressive mobility ≥70% after selection * Total number of progressive motile spermatozoa recovered after TMS\> 10 million * Patient affiliated or beneficiary of a social security scheme * Patient having been informed and not opposing to this research.
Exclusion criteria
* Male over 65 years-old * Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of embryotoxicity | 1 day | 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). |
Countries
France
Outcome results
None listed