Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000847819
Ethics application status
Approved
Date submitted
13/05/2021
Date registered
1/07/2021
Date last updated
2/06/2022
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Artificial Intelligence for Sperm Selection in Artificial Reproductive Technology
Scientific title
Development of an Artificial Intelligence Tool for Sperm Selection in Artificial Reproductive Technology
Secondary ID [1] 304219 0
Nil known
Universal Trial Number (UTN)
Not Available
Trial acronym
AISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 321920 0
Condition category
Condition code
Reproductive Health and Childbirth 319645 319645 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
9
Target follow-up type
Months
Description of intervention(s) / exposure
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.
Intervention code [1] 320556 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327508 0
Collection of images of selected sperm prior to injection during the ICSI process.
Timepoint [1] 327508 0
Images collected during the ICSI process and the cumulative data will be assessed at the conclusion of the study
Secondary outcome [1] 395454 0
Collection of semen analysis data on sperm samples used for ICSI during IVF treatment. These include count, motility, morphology and DNA damage. This is a composite secondary outcome.
Timepoint [1] 395454 0
Data collected during the ICSI process with cumulative data will be assessed at the conclusion of the study
Secondary outcome [2] 397591 0
Oocyte Fertilisation will be collected from laboratory worksheets and the reproductive information management system (RIMS) used by Monash IVF.
Timepoint [2] 397591 0
16-18 hours post injection of oocyte (The ICSI process is the injection of sperm into the egg).
Secondary outcome [3] 397592 0
Embryo development information will be collected from laboratory worksheets and the reproductive information management system (RIMS) used by Monash IVF.
Timepoint [3] 397592 0
6 days post ICSI procedure
Secondary outcome [4] 397593 0
Clinical pregnancy information will be collected from the reproductive information management system (RIMS) used by Monash IVF.
Timepoint [4] 397593 0
6 weeks post embryo transfer or frozen embryo transfer of an embryo created in this cycle
Secondary outcome [5] 397594 0
Live Birth information will be collected from the reproductive information management system (RIMS) used by Monash IVF.
Timepoint [5] 397594 0
Up to 12 months post embryo transfer or frozen embryo transfer with an embryo created from this cycle

Eligibility
Key inclusion criteria
• Any patient for whom ICSI is considered as a treatment option will be eligible
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
328 participant couple are required to be able to detect an effect size of 0.2 (standardised mean difference between the AI prediction and IVF outcome), based on p-value of 0.05 and power of 0.95 (recommended value).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
656
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19446 0
Monash IVF - Clayton - Clayton
Recruitment hospital [2] 19447 0
Monash IVF - Hawthorn - Hawthorn
Recruitment postcode(s) [1] 34037 0
3168 - Clayton
Recruitment postcode(s) [2] 34038 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 308596 0
Commercial sector/Industry
Name [1] 308596 0
Monash IVF Group
Country [1] 308596 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Monash IVF Group
Address
1 Pelaco, building 1/21-31 Goodwood St, Richmond VIC 3121
Country
Australia
Secondary sponsor category [1] 309720 0
None
Name [1] 309720 0
Address [1] 309720 0
Country [1] 309720 0
Other collaborator category [1] 281781 0
University
Name [1] 281781 0
The University of Melbourne
Address [1] 281781 0
Parkville, VIC, 3010
Country [1] 281781 0
Australia
Other collaborator category [2] 281782 0
University
Name [2] 281782 0
Monash University
Address [2] 281782 0
Wellington Road, Clayton, VIC 3800
Country [2] 281782 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308530 0
Monash Health Ethics Committee
Ethics committee address [1] 308530 0
Ethics committee country [1] 308530 0
Australia
Date submitted for ethics approval [1] 308530 0
03/03/2021
Approval date [1] 308530 0
17/03/2021
Ethics approval number [1] 308530 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111030 0
A/Prof Deirdre Zander-Fox
Address 111030 0
Monash IVF
Level 1 Monash Surgical Private Hospital,
252-256 Clayton Rd
Clayton
VIC
3168
Country 111030 0
Australia
Phone 111030 0
+61 0488445051
Fax 111030 0
Email 111030 0
[email protected]
Contact person for public queries
Name 111031 0
Katherine Veale
Address 111031 0
Monash IVF
Level 1 Monash Surgical Private Hospital,
252-256 Clayton Rd
Clayton
VIC
3168
Country 111031 0
Australia
Phone 111031 0
+61 03 9590 8315
Fax 111031 0
Email 111031 0
[email protected]
Contact person for scientific queries
Name 111032 0
Katherine Veale
Address 111032 0
Monash IVF
Level 1 Monash Surgical Private Hospital,
252-256 Clayton Rd
Clayton
VIC
3168
Country 111032 0
Australia
Phone 111032 0
+61 0409297951
Fax 111032 0
Email 111032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data, after de-identification, underlying published results only
When will data be available (start and end dates)?
After publication with no end date
Available to whom?
On a case by case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
Only to acheive the aims of the approved proposal
How or where can data be obtained?
Access subject to approvals by Prinicpal Investigator - [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.