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

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

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.

Study Overview

• Status: Recruiting
• Conditions: in Vitro Fertilization; Human Sperm Survival Assay; Embryotoxicity
• Intervention / Treatment: Biological: HSSA test

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 Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Recruiting
    • Private Hospital of Parly II-Le Chesnay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Male between 18 and 65 years-old with normal spermogram

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sperm with normal spermogramm and more than 10 millions spermatozoids; Normal spermogramm : concentration ≥15 million / ml or total count> 39 million, progressive mobility ≥32% or total mobility ≥40%	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network; Private hospital Parly II

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Anticipated): November 10, 2021
• Study Completion (Anticipated): March 4, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A01972-37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No