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

NCT05100784 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2021-10-29

No results posted yet for this 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.

Conditions

  • Human Sperm Survival Assay
  • Embryotoxicity
  • in Vitro Fertilization

Interventions

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.

Sponsors & Collaborators

  • European Clinical Trial Experts Network

    collaborator OTHER

  • Private hospital Parly II

    collaborator UNKNOWN

  • Ramsay Générale de Santé

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2021-11-10
Completion
2022-03-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05100784 on ClinicalTrials.gov