NCT05100784

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,800 (estimated)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Human Sperm Survival Assay
• Embryotoxicity
• in Vitro Fertilization

Interventions

Type	Name	Description
BIOLOGICAL	HSSA 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.

Timeline

• Start date: 2021-03-03
• Primary completion: 2021-11-10
• Completion: 2022-03-04
• First posted: 2021-10-29
• Last updated: 2021-10-29

Locations

1 site across 1 country: France