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

Completed

• Conditions: Infertility, Male

• Registration Number: NCT04061486
• Lead Sponsor: IVI Sevilla

Brief Summary

The goal of this observational study is to compare clinical outcomes of two techniques for sperm cell sorting, microfluidic sorting and magnetic activated cell sorting (MACS) technique, in males with high DNA fragmentation within an assisted reproductive treatment. The main questions it aims to answer are:

* Does microfluidic sorting improve pregnancy rate compared to MACS?

* Does microfluidic sorting improve fertilization rate compared to MACS?

* Does microfluidic sorting improve implantation rate compared to MACS?

* Does microfluidic sorting improve blastocyst development rate compared to MACS?

Participants will deposit an eyaculate sample that will be analyzed for DNA fragmentation using a aliquot, then split in two to perform MACS and the microfluidic sorting. Both will be tested for DNA fragmentation (aliquotes) and used for the ICSI treatment with donor oocytes.

Researchers will compare both techniques to see if the selection of the best functional spermatozoa with less DNA fragmentation and clinical outcomes improve.

Detailed Description

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.

Study Timeline

• Study Start: 2019-08-08
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-16
• Study First Posted: 2019-08-19
• Primary Completion: 2021-05-15
• Study Completion: 2022-01-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Oocyte recipient patients

Exclusion Criteria

• Sperm concentration < 5 Mill/ml
• Percentage of motile sperm < 15%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	Mar 2019 - Oct 2021	Total of positive pregnancies / total of patients with embryo transfer

Secondary Outcome Measures

Name	Time	Method
Implantation rate	Mar 2019 - Oct 2021	Total of implanted embryos / total of transferred embryos
Blastocyst rate	Mar 2019 - Oct 2021	Total of bastocyst / total of oocyte fertilized
Fertilization rate	Mar 2019 - Oct 2021	Total of oocyte fertilized / total of oocyte injected

Trial Locations

Locations (1)

IVI RMA Seville; 🇪🇸 Seville, Spain