The Human Sperm Survival Assay (HSSA) as an Internal Quality Control for the IVF Consumables (REPROTOX 2)
NCT ID: NCT05100784
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1800 participants
OBSERVATIONAL
2021-03-03
2022-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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%
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
18 Years
65 Years
MALE
No
Sponsors
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European Clinical Trial Experts Network
OTHER
Private hospital Parly II
UNKNOWN
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Private Hospital of Parly II-Le Chesnay
Le Chesnay, , France
Countries
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Central Contacts
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Facility Contacts
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Jean-François Oudet
Role: primary
Marie-Hélène Barba
Role: backup
Other Identifiers
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2020-A01972-37
Identifier Type: -
Identifier Source: org_study_id