The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)

Ramsay Générale de Santé

Status

Unknown

Conditions

Embryotoxicity

Human Sperm Survival Assay

in Vitro Fertilization

Treatments

Biological: HSSA test

Study type

Observational

Funder types

Other

Identifiers

NCT05100784

2020-A01972-37

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,800 estimated patients

Sex

Male

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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