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Artificial Intelligence for Sperm Selection in Artificial Reproductive Technology

Development of an Artificial Intelligence Tool for Sperm Selection in Artificial Reproductive Technology

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000847819
Acronym
AISS
Enrollment
656
Registered
2021-07-01
Start date
2022-08-02
Completion date
2024-08-01
Last updated
2022-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sperm selection for ICSI is a highly subjective process based on the embryologist’s perception of what looks like the best sperm. There are currently no evidenced-based methods to select high quality sperm during the ICSI process. Given the huge body of evidence showing that sperm quality impacts both fertilization and child health, we predict the development of artificial intelligence (AI) assisted sperm selection will have positive impacts for infertile couples and their children. This study aims to capture images of sperm shape and movement using a video imaging system during ICSI. This information from each sperm that is injected will be matched with each embryo outcome, as well as the clinical information and reproductive outcomes from the IVF cycle to create a machine learning tool to choose the best sperm for ICSI. Machine learning is a type of AI, where a computer uses mathematical models based on sample data, known as training data, to make predictions or decisions without being explicitly programmed to do so i.e., without human bias. The information collected will be used to develop a machine learning sperm selection tool to aid the scientist in selecting the sperm during ICSI with best potential for fertility.

Interventions

Intracytoplasmic spermatid injection (ICSI) is part of IVF treatment where the a single sperm is injected into a single oocyte. It treats male factor infertility. During an IVF cycle female participants have their oocytes collected during an Oocyte Pick Up under sedation in an operating theatre. The male participant produces a semen sample by masturbation around the time their partner is in theatre. The ICSI procedure is performed by an experienced Clinical Embryologist. All these procedures

Intracytoplasmic spermatid injection (ICSI) is part of IVF treatment where the a single sperm is injected into a single oocyte. It treats male factor infertility. During an IVF cycle female participants have their oocytes collected during an Oocyte Pick Up under sedation in an operating theatre. The male participant produces a semen sample by masturbation around the time their partner is in theatre. The ICSI procedure is performed by an experienced Clinical Embryologist. All these procedures are part of their clinical treatment and occur regardless if they participate in the study or not. The observation will involve the Clinical Embryologist pressing record and the entire procedure will be video recorded off the microscope. The time required for the procedure depends on the number of eggs and the difficulty in finding appropriate sperm to inject. It takes approximately 2 minutes to inject an egg. Participants can only be enrolled for 1 IVF cycle. The participants have no involvement in this procedure as the gametes have already been collected from them. The only involvement required of male participants is to fill out the study specific semen production form. This is the same form all patients must fill out but with 4 additional questions. The sample is provided for the IVF treatment, not the study. All maternal, paternal and embryo information collection requires no involvement from the participants. This is all information routinely collected as part of the IVF treatment process. The end point of follow up for the participants is 9 months after an embryo transfer of an embryo created during this IVF cycle. This includes any subsequent frozen embryo transfers. We will be looking at live birth outcomes at this point. There is no involvement required from the patients other than filling out the semen production form. Live birth data must be collected by the IVF Clinic as part of their reporting obligations. The semen production will be happening in semen production rooms, or off site in the participants home. The ICSI procedure will be recorded on microscopes located inside the embryology labs at Clayton and Hawthorn sites. The researcher is not assessing the motility, direction of travel or morphology of the sperm selected in the video recording. They will be cropping out footage of the particular injected sperm and those images will be inputs into a machine learning algorithm. The algorithm may be checking head and neck morphology but this has not determined at this stage. Analysis of residual semen samples: A semen analysis including test simplets pre-stained slides for morphology. Morphology assessment as per WHO Examination and processing of human semen. Halosperm for DNA damage assessment and ROS level assessment using DCFDA and/or MitoSOX Red.

Sponsors

Monash IVF Group
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Any patient for whom ICSI is considered as a treatment option will be eligible

Exclusion criteria

• Patients with surgical sperm collection requirements • Patients having calcium activation/aggressive ICSI and or HA ICSI • Patients using frozen gametes • Patients involved in the Donor program (oocyte and sperm)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026