Sperm Selection Using Microfluidic Technology

NCT04997070 | Completed

• 1 other identifier: 2021-185
• Study Type: observational
• Target: 1,038
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study has been organised to investigate whether microfluidic technology may be considered as a new procedure for routine sperm preparation during assisted reproduction. This is a technique that is already used in other centres. The Microfluidic Sperm Sorting (MSS) technology reduces the time of sample preparation while selects a sperm population with better motility and less DNA fragmentation as compared to routine procedures. This med-ical device is already CE marked. Having the intention to implement this technology in our department, we conduct this study to investigate whether the use of MSS has at least the same impact, if not better, on fertilization and embryo quality as compared to standard sperm selection procedures.

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (1)

• Embryo quality

  Compare the embryo quality (Gardner score - Scale blastocyst 1-6 where 6 is best; Inner cell mass A-D where A is best; Throphectoderm A-C where A is best) on day 5 between the two groups.

  2 years

Secondary Outcomes (2)

• Fertilization rate

  2 years

• Embryo morphokinetic parameters

  2 years

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Couples undergoing ICSI procedure in CRG UZ Brussel will be included in the trial if they fulfil the inclusion criteria listed.

You may qualify if:

• ICSI cycles planned for embryo transfer or 'freeze all' procedure
• Day 5 or day 3/5 embryo culture
• Fresh semen samples with ≥ 1x106 sperm/ml (raw) and Motility of 30% Grade A+B
• At least 6 follicles of ≥14 mm at the day of hCG administration
• Minimum 6 mature oocytes after oocyte pick up

You may not qualify if:

• Cycles with frozen semen sample
• Cycles with testicular sample
• In vitro fertilization (IVF) cycles
• In vitro maturation cycles
• Managed Natural Cycles (MNC)
• Egg bank- Acceptors
• PGT cycles

Sponsors & Collaborators

• CRG UZ Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1900, Belgium

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Koen Wouters, Msc

  Brussels IVF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Embryologist

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 9, 2021
• Study Start: May 16, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)