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Completed

NCT Number: NCT05100784

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

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.

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Key information

Conditions

Human Sperm Survival Assay Embryotoxicity In Vitro Fertilization

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Private Hospital of Parly II-Le Chesnay

Le Chesnay, 78150, France

About this study

The main objective is to assess the embryotoxicity of the main IVF consumables using the HSSA test before their introduction to the IVF laboratory.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HSSA test

Biological

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • European Clinical Trial Experts Network
  • Private hospital Parly II

Registry information

Official study title

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

Acronym: REPROTOX 2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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