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

Last updated: October 28, 2021
Sponsor: Ramsay Générale de Santé
Overall Status: Active - Recruiting

Phase

N/A

Condition

In Vitro Fertilization

Treatment

N/A

Clinical Study ID

NCT05100784
2020-A01972-37
  • Ages 18-65
  • Male

Study 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

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

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

Study Design

Total Participants: 1800
Study Start date:
March 03, 2021
Estimated Completion Date:
March 04, 2022

Study 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.

Connect with a study center

  • Private Hospital of Parly II-Le Chesnay

    Le Chesnay, 78150
    France

    Active - Recruiting

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