Automated Sperm Selection
A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI
1 other identifier
interventional
330
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2021
CompletedFirst Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedMarch 4, 2024
March 1, 2024
3.7 years
October 15, 2021
March 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Fertilization rate
Fertilization is defined as the visualization of 2 pronuclear at day 1 post ICSI. The proportion of fertilized eggs for each patient will be calculated as fertilization rate. Each patient's data will be aggregated to calculate the overall fertilization rate for all patients.
1 day
Blastocyst formation rate
The proportion of fertilized embryos classified as blastocysts at day 5 or day 6 of development.
5 or 6 days
Embryo morphology grade as evaluated by the SART grading system
The morphology grade (good, fair, poor) for each embryo will be evaluated. Grades for all embryos of each patient will be summarized.
5 or 6 days
Secondary Outcomes (3)
Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.
5 or 6 days
Differences in the proportion of euploid and aneuploid embryos between the two groups
5 or 6 days
Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.
5 or 6 days
Study Arms (2)
Standard sperm selection
NO INTERVENTIONIn the control group the oocytes will be injected with sperm that is selected by embryologists using conventional methods in the IVF lab.
Automated sperm selection
EXPERIMENTALThe only intervention is the additional sperm selection step using software immediately prior to ICSI.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients undergoing ICSI
- Female partner between 19-43 years of age using own or donor oocytes
You may not qualify if:
- Patients who do not provide informed consent
- Patients with less than 6 mature eggs collected
- Patients undergoing IVF without ICSI
- Morphology \<4% normal forms
- % immotile sperm
- Cases where surgically-retrieved sperm is used for ICSI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Create Fertility Centerlead
- University of Torontocollaborator
Study Sites (1)
CReATe Fertility Centre
Toronto, Ontario, M5G 1N8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Sun, PhD
University of Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2021
First Posted
February 15, 2022
Study Start
January 20, 2021
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
March 4, 2024
Record last verified: 2024-03