Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip

Infertility, Male Clinical Trial

— FERTIMACS  

Official title:

Sperm Separation Efficiency to Maximize Pregnancy Rates: MACS vs. FERTILE Chip

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04061486
• Other study ID #: 1904-SEV-050-CR
• Status: Active, not recruiting
• Start date: August 8, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2021
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In assisted reproductive technology (ART), the diagnosis of male infertility has been conducted based on the assessment and analysis of sperm concentration, motility and morphology with the aim of obtaining the best quality of spermatozoa. Any type of damage present in sperm DNA can lead to ART failure. Sperm DNA fragmentation might be the most frequent cause of paternal DNA anomaly transmitted to offspring, and is found in a variable percentage of spermatozoa in subfertile and infertile men. Such DNA fragmentation is negatively correlated with semen quality and consequently, there is a need to develop sperm separation techniques that facilitate retrieval of as many spermatozoa with normal DNA integrity as possible from ejaculated semen.

Because of centrifugation steps associated to swim-up or density-gradient can induce sperm DNA fragmentation via reactive oxygen species (ROS), microfluidic sperm sorters are being used to isolate motile human spermatozoa based on fluid dynamics. It seems to be that using this separation method, spermatozoa do not undergo added physical stress from sources such as a centrifuge. Hence, this new technology has been proposed to minimize DNA damage. In this study, we aim to determine if microfluidic sorting improves the selection of the best functional and with lower DNA fragmentation spermatozoa when compared to magnetic activated cell sorting (MACS) in split semen samples, and increases clinical outcomes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: October 31, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Oocyte recipient patients

Exclusion Criteria:

• Sperm concentration < 5 Mill/ml

• Percentage of motile sperm < 15%

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Locations

Country	Name	City	State
Spain	IVI RMA Seville	Seville

Sponsors (2)

Lead Sponsor	Collaborator
IVI Sevilla	IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Total of positive pregnancies / total of patients with embryo transfer	Mar 2019 - Oct 2021
Secondary	Fertilization rate	Total of oocyte fertilized / total of oocyte injected	Mar 2019 - Oct 2021
Secondary	Implantation rate	Total of implanted embryos / total of transferred embryos	Mar 2019 - Oct 2021
Secondary	Blastocyst rate	Total of bastocyst / total of oocyte fertilized	Mar 2019 - Oct 2021