UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047539 |
|---|---|
| Receipt number | R000054213 |
| Scientific Title | A prospective randomized controlled trial of the therapeutic efficacy of PICSI in patients with repeated miscarriage after embryo transfer and patients with teratozoospermia |
| Date of disclosure of the study information | 2022/04/20 |
| Last modified on | 2022/04/20 16:47:37 |
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Basic information
Public title
A study of the therapeutic efficacy of PICSI in patients with repeated miscarriages after embryo transfer and patients with teratozoospermia
Acronym
A study of the therapeutic efficacy of PICSI
Scientific Title
A prospective randomized controlled trial of the therapeutic efficacy of PICSI in patients with repeated miscarriage after embryo transfer and patients with teratozoospermia
Scientific Title:Acronym
A study of the therapeutic efficacy of PICSI
Region
| Japan |
Condition
Condition
Repeated miscarriage patients after embryo transfer, Teratozoospermic patients
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to randomly divide patients with repeated miscarriages or teratozoospermia into ICSI and PICSI groups, compare their clinical outcomes, confirm the therapeutic efficacy of PICSI, and clarify the indications for PICSI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Day3 grade 1 embryo rate
Key secondary outcomes
Fertilization rate, Blastocysto development rate, Clinical pregnancy rate, Abortion rate, HBA score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Sperm selection using hyaluronic acid
Interventions/Control_2
Sperm selection based on morphology
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Repeated miscarriages or implantation failure after embryo transfer.
Teratozoospermic patients.
Patients who have given written consent to participate in this study.
Key exclusion criteria
Male infertile patients eligible for TESE/TESA/PESA.
Patients undergoing ICSI using frozen thawed sperm.
Patients who used study reagents within 30 days prior to egg retrieval.
Patients who cannot have given written consent to participate in this study.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | TAKETOSHI |
| Middle name | |
| Last name | SHIMIZU |
Organization
Shibakoen Kamiyama Clinic
Division name
Laboratory
Zip code
1050014
Address
Daiyu Building 1F shiba 2-9-10 minatoku Tokyo
TEL
0364145641
s-kamiyamaclinic.ivflabo@outlook.jp
Public contact
Name of contact person
| 1st name | TAKETOSHI |
| Middle name | |
| Last name | KAMIYAMA |
Organization
Shibakoen Kamiyama Clinic
Division name
General director
Zip code
1050014
Address
Daiyu Building 1F shiba 2-9-10 minatoku Tokyo
TEL
0364145641
Homepage URL
s-kamiyamaclinic@jcom.home.ne.jp
Sponsor or person
Institute
Shibakoen Kamiyama Clinic
Institute
Department
Personal name
Funding Source
Organization
Shibakoen Kamiyama Clinic
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
Institutional Review Board of Shibakoen Kamiyama Clinic
Address
105-0014 Daiyu Building 1F shiba 2-9-10 minatoku Tokyo
Tel
0364145641
s-kamiyamaclinic.ivflabo@outlook.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 05 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054213
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
