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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04061486
Other study ID # 1904-SEV-050-CR
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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%

Study Design


Related Conditions & MeSH terms


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
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