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

• Conditions: Human Sperm Survival Assay; in Vitro Fertilization; Embryotoxicity
• Interventions: Biological: HSSA test

• Registration Number: NCT05100784
• Lead Sponsor: Ramsay Générale de Santé

Brief 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.

Study Timeline

• Study Start: 2021-03-03
• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29
• Primary Completion: 2021-11-10
• Study Completion: 2022-03-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sperm with normal spermogramm and more than 10 millions spermatozoids	HSSA test	Normal spermogramm : concentration ≥15 million / ml or total count\> 39 million, progressive mobility ≥32% or total mobility ≥40%

Primary Outcome Measures

Name	Time	Method
Presence of embryotoxicity	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).

Trial Locations

Locations (1)

Private Hospital of Parly II-Le Chesnay; 🇫🇷 Le Chesnay, France