NCT05383599

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 16, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

May 13, 2022

Last Update Submit

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

Sexmale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Neelke De Munck

    Brussels IVF

    STUDY DIRECTOR

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

Locations