UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049721 |
|---|---|
| Receipt number | R000056634 |
| Scientific Title | 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) |
| Date of disclosure of the study information | 2023/01/11 |
| Last modified on | 2024/04/26 16:56:51 |
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Basic information
Public title
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)
Acronym
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)
Scientific Title
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)
Scientific Title:Acronym
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)
Region
| Japan | Australia |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of the study is to prove that the Felix System is not inferior in embryo utilisation rate (EUR) to the dual Density Gradient Centrifugation (DGC) and Swim-up (SU) method of spermatozoa separation when using Intracytoplasmic Spermatozoa Injection (ICSI) fertilisation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
embryo utilisation rate (EUR)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The Felix spermatozoa separation method
Interventions/Control_2
the dual Discontinuous Gradient Centrifugation and Swim-Up method
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
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 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
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL
06-6136-3344
tishikawa@reposaka.jp
Public contact
Name of contact person
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL
06-6136-3344
Homepage URL
tishikawa@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Memphasys Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Reproduction Clinic Osaka
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
Tel
06-6136-3344
tishikawa@reposaka.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
プロダクションクリニック大阪（大阪府）/ Reproduction Clinic Osaka (Osaka)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056634
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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