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Automated Sperm Selection

NCT05240469 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2024-03-04

No results posted yet for this study

Summary

Intracytoplasmic sperm injection (ICSI) is one of the standard clinical treatments for infertility. ICSI involves the injection of a single sperm into an oocyte with a sharp micropipette. Injecting a sperm with DNA fragmentation (i.e., physical breakage of the DNA double strands) into the oocyte deterministically lowers the IVF fertilization rate \[1\]\[2\] and increases the miscarriage rate \[3\]\[4\]. Since the invention of ICSI in 1992, single sperm selection in ICSI has been made manually by embryologists, who select sperm by qualitatively choosing sperm with "good" motility and/or morphology based on their empirical experience. This involves significant subjectivity and inconsistency. We have developed a robotic system to select sperm with low sperm DNA fragmentation. Automated sperm selection also eliminates the subjectivity and inconsistency in manual sperm selection. The system consists of a camera to acquire images of sperm and a software to analyze the images. Embryologists select sperm by observing the same sperm characteristics as in the software criteria (e.g., speed etc.), but the software provides a more accurate and quantitative measure of sperm characteristics, thus ensuring the selected sperm have low DNA fragmentation.

Conditions

Interventions

DEVICE

Automated sperm selection software

The software measures both morphology and motility similar to an embryologist but provides a more accurate and consistent measure of sperm characteristics. Embryologists use their experience to qualitatively judge if an individual sperm is "suitable for injection" based on morphology and motility. Similarly, the software follows a two-step process: firstly, a computer vision algorithm measures characteristics of all sperm in a given field, including motility and morphology; secondly, the software algorithm then uses a set of quantitative criteria to categorize and identify the most developmentally competent sperm with normal characteristics. All the characteristics that the software calculate are defined by the WHO guidelines, and the software does not propose or define new parameters.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Create Fertility Center

    lead OTHER

Principal Investigators

  • Yu Sun, PhD · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
43 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05240469 on ClinicalTrials.gov