None listed
Conditions
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.
Interventions
The Felix™ System 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™ System. The laboratory technician will first add media into the Felix System Cartridge. The technician will then add the raw semen sample into the sample chamber. The Felix™ System will then run for six minutes before the technician collects the sperm from the harvest chamber.
All sperm samples
The Felix™ System 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™ System. The laboratory technician will first add media into the Felix System Cartridge. The technician will then add the raw semen sample into the sample chamber. The Felix™ System 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™ System. 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.
Sponsors
Memphasys Limited
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed