Characterization of Sperm Population Following Different Selection Procedures
CROSP
1 other identifier
observational
50
1 country
1
Brief Summary
The present study aims to determine which of the sperm selection techniques used in IVF (In Vitro Fertilization) laboratory leads to selection of the best/healthiest sperm population based on their morpho-functional parameters. Different procedures are currently used in our laboratory to select the sperm population that will be used to inseminate the oocytes: Density Gradient Centrifugation (DGC), DGC in combination with Magnetic Activated Sperm Sorting (MACS), and Microfluidic Sperm Sorting (MSS). The sperm cells selected by these techniques will be evaluated for specific morpho-functional features such as, motility, morphological abnormalities, and apoptotic status \[phosphatidylserine translocation (early stages of apoptosis)\] and DNA (Deoxyribonucleic Acid) fragmentation as an indicator of stages of apoptosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
May 20, 2022
CompletedStudy Start
First participant enrolled
July 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedFebruary 6, 2023
February 1, 2023
6 months
May 13, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
DNA Fragmentation Index
percentage of sperm cells with DNA fragmentation out of selected sperm cells
1 year
Progressive Motility Index
percentage of sperm cells with progressive motility out of selected sperm cells
1 year
Early Apoptosis Index
percentage of early apoptotic sperm cells out of selected sperm cells
1 year
Normal Morphology Index
percentage of morphological normal sperm cells out of selected sperm cells
1 year
Concentration
number of sperm cells per ml of ejaculated semen sample
1 year
Eligibility Criteria
Unused raw semen samples after diagnostic tests will be included in the study if they fulfil the inclusion criteria
You may qualify if:
- semen volume ≥1.5ml
- sperm concentration \>20 x 106 spermatozoa/ml
- ≥30% progressive motility
You may not qualify if:
- semen samples processed for immediate or later use in Assisted Reproductive Medicine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel CRG
Brussels, 1090, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Neelke De Munck
Brussels IVF
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 13, 2022
First Posted
May 20, 2022
Study Start
July 16, 2022
Primary Completion
January 16, 2023
Study Completion
August 1, 2023
Last Updated
February 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share