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Completed
NCT05100784
The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)
Conditions: Human Sperm Survival Assay, Embryotoxicity, in Vitro Fertilization
Sex: Male
Ages: 18 Years – 65 Years
Enrollment: 826
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Location: Private Hospital of Parly II-Le Chesnay Le Chesnay
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05100784). StuddyBuddy aggregates publicly available trial information.