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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infertility, Male

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Oocyte recipient patients Exclusion Criteria: Sperm concentration < 5 Mill/ml Percentage of motile sperm < 15%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental arm<br>One half of the oocyte cohort is microinjected with sperm selected by the Fertile technique, while the other half of the patient's oocyte cohort is microinjected with sperm selected by the MACS technique. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Total of positive pregnancies / total of patients with embryo transfer | Mar 2019 - Oct 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Total of oocyte fertilized / total of oocyte injected | Mar 2019 - Oct 2021 | 
| Implantation rate | Total of implanted embryos / total of transferred embryos | Mar 2019 - Oct 2021 | 
| Blastocyst rate | Total of bastocyst / total of oocyte fertilized | Mar 2019 - Oct 2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MACS, DNA fragmentation, Sperm selection