InfertilityNCT05240469
Automated Sperm Selection
A study testing Automated sperm selection software in people with Infertility, run by Create Fertility Center at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 43 years
- Conditions the study is for
- Infertility
- What is being tested?
- Automated sperm selection software
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 43 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing ICSI
- Female partner between 19-43 years of age using own or donor oocytes
Who cannot join
- Patients who do not provide informed consent
- Patients with less than 6 mature eggs collected
- Patients undergoing IVF without ICSI
- Morphology <4% normal forms
- 100% immotile sperm
- Cases where surgically-retrieved sperm is used for ICSI
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CReATe Fertility Centre
Toronto, Ontario, M5G 1N8
Clinical Research Coordinator, 416-323-7727 ext. 2950, researchcoordinator@createivf.com
Justin Tan, 416-323-7727 ext. 2124, justint@createivf.com
About this study
Official title: A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI
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.
Read the detailed description
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]. Patients with high sperm DNA fragmentation suffer from repeated IVF failures [8], causing heavy burdens on families and the healthcare system. 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. The software automatically measures the 9 motility parameters (e.g., curvilinear speed, path linearity, etc.) and 11 morphology parameters (e.g., head ellipticity, midpiece width etc.). All these 20 parameters are defined by the WHO guidelines [9]. 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
- Infertility
- Being tested
- Automated sperm selection software
- Keywords
- In Vitro Fertilization, Embryology, Oocyte, Sperm, Automated Sperm Selection, DNA Fragmentation Index
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated sperm selection softwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard sperm selection | No intervention | In 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 | Experimental | The only intervention is the additional sperm selection step using software immediately prior to ICSI. Receives: Device: Automated sperm selection software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Blastocyst formation rate
The proportion of fertilized embryos classified as blastocysts at day 5 or day 6 of development.
Measured: 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.
Measured: 5 or 6 days
Secondary outcomes (3)
Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.
Embryo morphokinetic parameters will be calculated from time-lapse embryo development videos using an EmbryoScope embryo culture system. The evaluated morphokinetic parameters for each embryo include:
- time of pronuclei formation
- time of cleavage to a two-cell embryo
- time of cleavage to a three-cell embryo
- time of cleavage to a four-cell embryo
- time of cleavage to a six-cell embryo
- time of cleavage to a eight-cell embryo
- time to full blastocyst
Measured: 5 or 6 days
Differences in the proportion of euploid and aneuploid embryos between the two groups
Embryo ploidy will be evaluated by preimplantation genetic testing technique for aneuploidy.
Measured: 5 or 6 days
Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.
We will also compare primary outcome measures (fertilization rate, PGT-A results, blastocyst formation rate, embryo grade) of all embryos in the study (control and study group) to the overall rates in the clinic as a measure of quality assurance of the study.
Measured: 5 or 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start20 Jan 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Create Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Yu Sun, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240469
- Sponsor's protocol ID
- 2395
- Status last verified
- Mar 2024
- First submitted
- 15 Oct 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Parallel-group, Non-inferiority Study to Compare the Efficacy of an Automated Sperm Selection Method Versus Manual Sperm Selection for ICSI
- ClinicalTrials.gov ID
- NCT05240469
- Acronym / sponsor ID
- 2395
- Conditions
- Infertility
- Keywords
- In Vitro Fertilization, Embryology, Oocyte, Sperm, Automated Sperm Selection, DNA Fragmentation Index
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Create Fertility CenterUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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]. Patients with high sperm DNA fragmentation suffer from repeated IVF failures [8], causing heavy burdens on families and the healthcare system. 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. The software automatically measures the 9 motility parameters (e.g., curvilinear speed, path linearity, etc.) and 11 morphology parameters (e.g., head ellipticity, midpiece width etc.). All these 20 parameters are defined by the WHO guidelines [9]. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard sperm selection | No intervention | –In 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 | Experimental | Device: Automated sperm selection softwareThe only intervention is the additional sperm selection step using software immediately prior to ICSI. |
Who may qualify
- Ages
- 19 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing ICSI
- Female partner between 19-43 years of age using own or donor oocytes
Key exclusion criteria (6 listed)
- Patients who do not provide informed consent
- Patients with less than 6 mature eggs collected
- Patients undergoing IVF without ICSI
- Morphology <4% normal forms
- 100% immotile sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated sperm selection softwareThe 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. | Device | Automated sperm selection |
Primary outcome
Fertilization rate
Time frame: 1 day
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.
Blastocyst formation rate
Time frame: 5 or 6 days
The proportion of fertilized embryos classified as blastocysts at day 5 or day 6 of development.
Embryo morphology grade as evaluated by the SART grading system
Time frame: 5 or 6 days
The morphology grade (good, fair, poor) for each embryo will be evaluated. Grades for all embryos of each patient will be summarized.
3 secondary outcomes
Differences in early embryo cleavage divisions and late developmental (blastocyst) morphokinetics.
Time frame: 5 or 6 days
Differences in the proportion of euploid and aneuploid embryos between the two groups
Time frame: 5 or 6 days
Evaluation of patient demographic and stimulation cycle characteristics for confounding variables.
Time frame: 5 or 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Sun, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated sperm selection software in people with Infertility, run by Create Fertility Center at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clifford L Librach, MD (416-323-7727, drlibrach@createivf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.