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NCT05100784 Clinical Trial

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

in Vitro Fertilization Clinical Trial

— REPROTOX 2  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05100784
Other study ID # 2020-A01972-37
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 3, 2021
Est. completion date March 4, 2022

Study information
Verified date October 2021
Source Ramsay Générale de Santé
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1800
Est. completion date March 4, 2022
Est. primary completion date November 10, 2021
Accepts healthy volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
France Private Hospital of Parly II-Le Chesnay Le Chesnay

Sponsors (3)
Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network, Private hospital Parly II

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of embryotoxicity 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). 1 day
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