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

Sponsor
Ramsay Générale de Santé (Other)
Overall Status
Recruiting
CT.gov ID
NCT05100784
Collaborator
European Clinical Trial Experts Network (Other), Private hospital Parly II (Other)
1,800
Enrollment
1
Location
12
Anticipated Duration (Months)
149.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1800 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables
Actual Study Start Date :
Mar 3, 2021
Anticipated Primary Completion Date :
Nov 10, 2021
Anticipated Study Completion Date :
Mar 4, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Hospital of Parly II-Le Chesnay Le Chesnay France 78150

Sponsors and Collaborators

  • Ramsay Générale de Santé
  • European Clinical Trial Experts Network
  • Private hospital Parly II

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramsay Générale de Santé
ClinicalTrials.gov Identifier:
NCT05100784
Other Study ID Numbers:
  • 2020-A01972-37
First Posted:
Oct 29, 2021
Last Update Posted:
Oct 29, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 29, 2021