UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049597 |
|---|---|
| Receipt number | R000056483 |
| Scientific Title | Consideration of ICSI with acrosome reacted sperm(AR-ICSI) |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2023/12/19 09:15:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Consideration of ICSI with acrosome reacted sperm(AR-ICSI)
Acronym
Consideration of AR-ICSI
Scientific Title
Consideration of ICSI with acrosome reacted sperm(AR-ICSI)
Scientific Title:Acronym
Consideration of AR-ICSI
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of AR-ICSI in cases of poor embryo quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Developmental rate to the blastocyst stage
Key secondary outcomes
Acrosome reaction rate, Estrogen level, Progesterone level, fertilization rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ICSI with acrosome reacted sperm bound to zona pellucida in progesterone secreted from by cells retrieved with oocytes.
Interventions/Control_2
ICSI with sperm in progesterone secreted from by cells retrieved with oocytes.
Interventions/Control_3
Conventional ICSI
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ICSI, Number of ovum collected more than 6 oocytes
Key exclusion criteria
In vitro fertilization, Severe oligozoospermia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Nakaoka |
Organization
IVF Namba Clinic
Division name
medical office
Zip code
5500015
Address
1-17-28 Minamihorie Nishi-ku Osaka Japan
TEL
0665348824
nakaoka@ivfnamba.com
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Oura |
Organization
IVF Namba Clinic
Division name
Division of reproductive technology
Zip code
5500015
Address
1-17-28 Minamihorie Nishi-ku Osaka Japan
TEL
0665348824
Homepage URL
sumida@ivfnamba.com
Sponsor or person
Institute
IVF Namba Clinic
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IVF Namba Clinic
Address
1-17-28 Minamihorie Nishi-ku Osaka Japan
Tel
0665348824
sumida@ivfnamba.com
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 24 | 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 | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2027 | 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 | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056483
