A non-inferiority study to assess the safety and performance of the Felix System vs the dual Discontinuous Gradient Centrifugation and Swim-Up method to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART)

A non-inferiority study to assess the safety and performance of the Felix System vs the dual Discontinuous Gradient Centrifugation and Swim-Up method to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART) - A non-inferiority study to assess the safety and performance of the Felix System vs the dual Discontinuous Gradient Centrifugation and Swim-Up method to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049721

Enrollment

Registered

2023-01-11

Start date

2023-01-24

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Infertility

Interventions

The Felix spermatozoa separation method the dual Discontinuous Gradient Centrifugation and Swim-Up method

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male Inclusion Criteria: 1. Over 18 years of age 2. Has been abstinent from ejaculating for two to eight days prior to providing a semen sample. 3. Able to provide 2.3mL raw semen 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 1.2 ng/mL during screening if available 3. Over 18 and below 43 years of age at the time of booking of cycle

Exclusion criteria

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 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 OPU 13. Participants with a history of poor oocyte yield in the past 14. Known HIV-positive or other virally positive samples

Design outcomes

Primary

Measure	Time frame
embryo utilisation rate (EUR)	—

Secondary

Measure	Time frame
Spermatozoa concentration (millions/mL), Progressive motility (%), Vitality, DNA fragmentation via the SCSA method, Morphology (% normal), Fertilisation Rate (FR) 16 hours (+/- 1 hour) post ICSI insemination, Blastocyst Development Rate (BDR) calculated as the number of embryos that have reached blastocyte stage of Day 5 post ICSI insemination, Embryo Quality (EQ) at Day 5 based on the WHO EQ guidelines, Embryo Utilisation Rate (EUR) at Day 4, Day 5 or Day 6 post ICSI, Biochemical Pregnancy Rate (BPR) measured using Human Chorionic Gonadotropin (hCG) assay on or between Day 9 and Day 14 post embryo transfer, Clinical Pregnancy Rate (CPR) determined by fetal heartbeat measured via ultrasound examination between 6 to 7 weeks following the last menses. Non-clinical operating costs in running the Felix System compared to the DGC plus Swim Up method including time to complete spermatozoa separation, time required by the operator, cost of materials and personnel cost of the respective site spermatozoa separation operators, Usability data from operators of the Felix System compared to the dual DGC plus Swim Up separation method	—

Measure

Time frame

Spermatozoa concentration (millions/mL), Progressive motility (%), Vitality, DNA fragmentation via the SCSA method, Morphology (% normal), Fertilisation Rate (FR) 16 hours (+/- 1 hour) post ICSI insemination, Blastocyst Development Rate (BDR) calculated as the number of embryos that have reached blastocyte stage of Day 5 post ICSI insemination, Embryo Quality (EQ) at Day 5 based on the WHO EQ guidelines, Embryo Utilisation Rate (EUR) at Day 4, Day 5 or Day 6 post ICSI, Biochemical Pregnancy Rate (BPR) measured using Human Chorionic Gonadotropin (hCG) assay on or between Day 9 and Day 14 post embryo transfer, Clinical Pregnancy Rate (CPR) determined by fetal heartbeat measured via ultrasound examination between 6 to 7 weeks following the last menses. Non-clinical operating costs in running the Felix System compared to the DGC plus Swim Up method including time to complete spermatozoa separation, time required by the operator, cost of materials and personnel cost of the respective site spermatozoa separation operators, Usability data from operators of the Felix System compared to the dual DGC plus Swim Up separation method

—

Countries

Japan,Australia

Contacts

Public ContactTomomoto Ishikawa

Reproduction Clinic Osaka Reproduction Clinic Osaka

tishikawa@reposaka.jp06-6136-3344

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026