The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 826
- Locations
- 2
- Primary Endpoint
- Presence of embryotoxicity
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Presence of embryotoxicity
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported