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Trial registered on ANZCTR


Registration number
ACTRN12622000439741
Ethics application status
Approved
Date submitted
25/01/2022
Date registered
18/03/2022
Date last updated
26/08/2024
Date data sharing statement initially provided
18/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Felix Study: Assessing the Felix™ System vs Swim-Up and Discontinuous Gradient Centrifugation to isolate spermatozoa for use in assisted reproductive technology
Scientific title
A non-inferiority study to assess the to assess the safety and performance of the Felix™ System vs Swim-Up and Discontinuous Gradient Centrifugation to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART).
Secondary ID [1] 306191 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Felix-ICSI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
male infertility factor
 324894 0
assisted reproductive technology 324895 0
Condition category
Condition code
Reproductive Health and Childbirth 322332 322332 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Felix study device is used to separate sperm from a semen sample for all samples provided in the study. The male participant will provide a semen sample on the same day that it is processed by the Felix study device. The laboratory technician will first add media into the Felix device chamber. The technician will then add the raw semen sample into the sample chamber. The device will then run for six minutes before the technician collects the sperm from the harvest chamber.
All sperm samples will also be processed by the comparator (either using the swim up method or DGC)
The sperm sample from the Felix system will then be used to fertilize half of the oocytes collected from the female participant. The only study specific activity will be the sperm separation performed using the Felix device.

Oocyte collection from female participants will follow standard of care procedures.

The study will be monitored by an independent contract research organisation to check the validity of data and adherence to the study protocol.
Intervention code [1] 322593 0
Treatment: Other
Comparator / control treatment
Swim-up and Density Gradient Centrifugation are the two comparators for this study. These are the two most common global methods for sperm isolation depending on the grading of the semen sample provided. The semen samples will be allocated to either comparator method based on specific criteria with a 50/50 allocation.
In swim up, media is placed over the sample and the sperm swim to the top to be collected for the ICSI procedure.
In DGC, the sample is spun in a centrifuge, separating the most viable sperm to be collected for the ICSI procedure.
Half of the oocytes will be fertilised with sperm from the comparator treatment. The entire process will be completed by highly trained laboratory technicians.
Control group
Active

Outcomes
Primary outcome [1] 330097 0
The primary outcome of the study is the Embryo Utilisation Rate assessed as the number of usable Day 5 or Day 6 embryos achieved for fresh transfer and embryos suitable for freezing assessed by visual inspection under a microscope, where embryos are graded based on development stage and morphology of the inner cell mass and trophectoderm as per the WHO grading guidelines.
Timepoint [1] 330097 0
Assessed at day 5/6 post-fertilisation
Secondary outcome [1] 404871 0
Spermatozoa concentration (millions/mL) assessed visually under a microscope using a Makler counter.
Timepoint [1] 404871 0
Immediately before and after the sperm has been separated using the Felix System and either Density Gradient Centrifugation or Swim Up
Secondary outcome [2] 406877 0
Progressive motility (%) assessed visually by a laboratory technician.
Timepoint [2] 406877 0
Immediately before and after the sperm has been separated using the Felix System and either Density Gradient Centrifugation or Swim Up
Secondary outcome [3] 406878 0
Vitality assessed visually by a laboratory technician.
Timepoint [3] 406878 0
Immediately before and after the sperm has been separated using the Felix System and either Density Gradient Centrifugation or Swim Up
Secondary outcome [4] 406879 0
DNA fragmentation measured by two methods: HALO and TUNEL
Timepoint [4] 406879 0
Samples are snap frozen immediately before and after the sperm has been separated using the Felix System and either Density Gradient Centrifugation or Swim Up for the Core Lab to analyse at the end of the study.
Secondary outcome [5] 406880 0
Morphology (% normal) assessed visually by a laboratory technician.
Timepoint [5] 406880 0
Immediately before and after the sperm has been separated using the Felix System and either Density Gradient Centrifugation or Swim Up
Secondary outcome [6] 406881 0
Fertilisation Rate (FR) assessed visually by an embryologist.
Timepoint [6] 406881 0
16 hours (+/- 1 hour) post ICSI insemination
Secondary outcome [7] 406882 0
Blastocyst Development Rate (BDR) calculated as the number of embryos that have reached blastocyte stage per visual inspection under a microscope.
Timepoint [7] 406882 0
Day 5 post ICSI insemination
Secondary outcome [8] 406883 0
Embryo Quality (EQ) based on the WHO EQ guidelines
Timepoint [8] 406883 0
Day 5 post ICSI
Secondary outcome [9] 406884 0
Embryo Utilisation Rate (EUR) assessed visually by an embryologist
Timepoint [9] 406884 0
Day 5 or Day 6 post ICSI
Secondary outcome [10] 406885 0
Biochemical Pregnancy Rate (BPR) measured using Human Chorionic Gonadotropin (hCG) assay
Timepoint [10] 406885 0
Day 12 post embryo transfer
Secondary outcome [11] 406886 0
Clinical Pregnancy Rate (CPR) determined by foetal heartbeat measured via ultrasound examination
Timepoint [11] 406886 0
6 to 7 weeks following the last menses.
Secondary outcome [12] 406887 0
Non-clinical operating costs in running the Felix™ System compared to other methods including time to complete spermatozoa separation, time required by the operator, the type and amount of materials and personnel performing the respective site spermatozoa separation operators (i.e., Lab Technician, Andrologist, Embryologist, Other). These data points will be data-linked to clinic financial records to determine the total cost of each spermatozoa separation technique and used to assist in regulatory submissions.
Timepoint [12] 406887 0
During sperm separation
Secondary outcome [13] 406888 0
Usability data such as ease of use and preference of system from the operators of the Felix™ System compared to SU and DGC separation methods will be collected after each separation has been performed. A unique, study specific questionnaire will be used.
Timepoint [13] 406888 0
During the time of sperm separation

Eligibility
Key inclusion criteria
Male Inclusion Criteria:
1. Over 18 years of age
2. Has been abstinent from ejaculating for the three days prior to providing a semen sample.
3. Able to provide enough raw semen (measured using a serological pipette) to ensure study assessments can be completed in addition to standard of care based on the following criteria: a) 1.5mL of raw semen is required if the initial concentration is greater than 80M/mL and total motility is greater than 40% b) 1.9mL of raw semen is required if initial concentration is between 21-80M/mL and total motility is greater than 40% c) 1.9mL of raw semen is required if initial concentration is greater than 80M/mL and total motility between 4-40% d) 2.3mL of raw semen is required if the above criteria are not met
4. Participants scheduled to undergo ICSI

Female Inclusion Criteria:
1. Participants having blastocyst culture and either an embryo transfer or freezing embryo(s)
2. Minimum Anti Mullerian Hormone (AMH) of 6 lU/L during screening
3. Between 18 and 43 years of age at the time of booking of cycle
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Spermatozoa concentration < 2,000,000 / mL assessed using a Makler on the treatment day
2. Total motility < 10% assessed using a Makler on the treatment day
3. Participants having cleavage embryo culture and transfer
4. Participants intending on having more than one embryo implanted during this cycle (i.e., couple does not wish to have a singleton pregnancy) if an embryo transfer is elected
5. Participants undergoing standard In Vitro Fertilisation (IVF) insemination
6. Any surgically retrieved spermatozoa samples
7. Severe universal morphological defects of the head or tail such a headless, pinheads or globozoospermic spermatozoa or gross tail defects
8. Donor spermatozoa
9. Donor oocytes
10. Frozen spermatozoa
11. Frozen oocytes
12. Participants with less than 4 mature oocytes during the current round of Ovum Pick up (OPU)
13. Participants with a history of poor oocyte yield in the past
14. Known HIV-positive or other virally positive samples

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants enrolled in the study will have their sample processed with the investigational product. Allocation to the control (either Swim up or Density Gradient Centrifugation) will be based on the Andrologist's assessment of the characteristics of the sample. The Andrologist will follow best practice in determining which control to use.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In general, data will be summarized for each group using descriptive statistics. Categorical variables will be summarized by frequency counts and percentages per category. For continuous variables, the arithmetic mean, standard deviation, median, minimum and maximum will be provided. All collected parameters required by the protocol will be listed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/03/2022
Actual
13/06/2022
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
4/11/2024
Actual
Sample size
Target
104
Accrual to date
80
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 21457 0
Monash IVF - Clayton - Clayton
Recruitment hospital [2] 21458 0
Monash IVF - Parramatta - North Parramatta
Recruitment hospital [3] 21525 0
Monash IVF - Sydney CBD - Sydney
Recruitment hospital [4] 23914 0
Monash IVF Geelong - Geelong
Recruitment hospital [5] 25147 0
Monash IVF - Cremorne - Cremorne
Recruitment hospital [6] 26993 0
Monash IVF - Bondi Junction - Bondi Junction
Recruitment hospital [7] 26994 0
Repromed Adelaide - Dulwich - Dulwich
Recruitment hospital [8] 26995 0
Monash IVF - Penrith - Kingswood
Recruitment hospital [9] 26996 0
Monash IVF - West Leederville - West Leederville
Recruitment hospital [10] 26997 0
Fertility North Joondalup - Joondalup
Recruitment postcode(s) [1] 36358 0
3168 - Clayton
Recruitment postcode(s) [2] 36359 0
2151 - North Parramatta
Recruitment postcode(s) [3] 36432 0
2000 - Sydney
Recruitment postcode(s) [4] 39403 0
3220 - Geelong
Recruitment postcode(s) [5] 39404 0
2022 - Bondi Junction
Recruitment postcode(s) [6] 39405 0
5065 - Dulwich
Recruitment postcode(s) [7] 40815 0
3121 - Cremorne
Recruitment postcode(s) [8] 43068 0
2022 - Bondi Junction
Recruitment postcode(s) [9] 43069 0
2747 - Kingswood
Recruitment postcode(s) [10] 43070 0
6007 - West Leederville
Recruitment postcode(s) [11] 43071 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 310531 0
Commercial sector/Industry
Name [1] 310531 0
Memphasys Limited
Country [1] 310531 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Memphasys Limited
Address
30 Richmond Road
Homebush West NSW 2140
Country
Australia
Secondary sponsor category [1] 311704 0
None
Name [1] 311704 0
Address [1] 311704 0
Country [1] 311704 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310154 0
Bellberry Limited
Ethics committee address [1] 310154 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 310154 0
Australia
Date submitted for ethics approval [1] 310154 0
12/01/2022
Approval date [1] 310154 0
25/02/2022
Ethics approval number [1] 310154 0

Summary
Brief summary
The aim of the study is to prove that the Felix™ System is just as good as either or both the Density Gradient Centrifugation (DGC) and Swim-up (SU) methods of spermatozoa separation when using Intracytoplasmic Spermatozoa Injection (ICSI) fertilisation. This will be measured based on how many embryos could be immediately transferred, 5 or 6 days post fertilisation or retained and frozen for later transfer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116674 0
Prof Robert McLachlan
Address 116674 0
Monash Surgical Private Hospital, 252-256 Clayton Rd, Clayton VIC 3168
Country 116674 0
Australia
Phone 116674 0
+61 29890 9022
Fax 116674 0
Email 116674 0
[email protected]
Contact person for public queries
Name 116675 0
Naomi Bernecic
Address 116675 0
Monash IVF
1 Fennell St, North Parramatta NSW 2151
Country 116675 0
Australia
Phone 116675 0
+61 29890 9022
Fax 116675 0
Email 116675 0
[email protected]
Contact person for scientific queries
Name 116676 0
Naomi Bernecic
Address 116676 0
Monash IVF
1 Fennell St, North Parramatta NSW 2151
Country 116676 0
Australia
Phone 116676 0
+61 29890 9022
Fax 116676 0
Email 116676 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?
Listings of all de-identified data
When will data be available (start and end dates)?
Immediately following publication with no end date.
Available to whom?
Case by case basis after written permission is sought from the Sponsor.
Available for what types of analyses?
On a case by case basis after written permission is sought form the Sponsor.
How or where can data be obtained?
Directly from the sponsor on a case by case basis if made in writing to [email protected]


What supporting documents are/will be available?




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.