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OpenTrials
Completed

NCT Number: NCT04061486

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI RMA Seville

Seville, 41011, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Oocyte recipient patients

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Pregnancy rate

    Time frame: Mar 2019 - Oct 2021

    Total of positive pregnancies / total of patients with embryo transfer

Secondary outcomes

  1. Fertilization rate

    Time frame: Mar 2019 - Oct 2021

    Total of oocyte fertilized / total of oocyte injected

  2. Implantation rate

    Time frame: Mar 2019 - Oct 2021

    Total of implanted embryos / total of transferred embryos

  3. Blastocyst rate

    Time frame: Mar 2019 - Oct 2021

    Total of bastocyst / total of oocyte fertilized

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Collaborators

  • IVI Madrid

Registry information

Acronym: FERTIMACS

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2019
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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