UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062497 |
|---|---|
| Receipt number | R000071539 |
| Scientific Title | Evaluation of the Clinical Utility of PICSI |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/08/06 16:21:05 |
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Basic information
Public title
Evaluation of the Clinical Utility of Physiological Sperm Selection Using Hyaluronic Acid
Acronym
Evaluation of the Clinical Utility of PICSI
Scientific Title
Evaluation of the Clinical Utility of PICSI
Scientific Title:Acronym
Evaluation of the Clinical Utility of PICSI
Region
| Japan |
Condition
Condition
Infertility requiring intracytoplasmic sperm injection (ICSI)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical utility of physiological intracytoplasmic sperm injection (PICSI) using hyaluronic acid for sperm selection in patients with infertility requiring intracytoplasmic sperm injection (ICSI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical pregnancy rate following embryo transfer using embryos obtained by PICSI, defined as the proportion of pregnancies with a gestational sac confirmed by ultrasonography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
On the day of oocyte retrieval, physiological sperm selection using hyaluronic acid will be performed for spermatozoa to be used for intracytoplasmic sperm injection (ICSI). Motile spermatozoa capable of binding to hyaluronic acid will be selected as mature spermatozoa and used for ICSI (PICSI). The intervention will be performed once per oocyte retrieval cycle, with an intervention period of one day. Embryos will subsequently be cultured according to standard assisted reproductive technology procedures, and embryo transfer will be performed using the resulting embryos. Embryo development, pregnancy, and pregnancy outcomes will be followed.
Interventions/Control_2
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
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible:
1.Patients undergoing infertility treatment and assisted reproductive technology at our institution.
2.Patients for whom intracytoplasmic sperm injection (ICSI) is indicated.
3.Patients with a history of failure to obtain good-quality embryos following conventional ICSI; patients in whom sperm selection based on morphology and motility is difficult due to asthenozoospermia, teratozoospermia, or other sperm abnormalities; or patients with advanced paternal age.
4.Patients who have received sufficient information about the study and have provided written informed consent to participate voluntarily.
5.Patients otherwise considered appropriate for participation by the principal investigator or a study investigator.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1.Patients who do not meet the inclusion criteria.
2.Patients who do not provide written informed consent to participate in the study.
3.Patients with no motile spermatozoa for whom pharmacological stimulation, such as pentoxifylline treatment, is required to obtain motile spermatozoa.
4.Patients considered unable to participate in the study due to psychiatric disorders, psychiatric symptoms, or other relevant conditions.
5.Patients otherwise consider
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Zen |
| Middle name | |
| Last name | Watanabe |
Organization
Tohoku Universtiy Hospital
Division name
Gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7251
zen.watanabe.e8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Zen |
| Middle name | |
| Last name | Watanabe |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7251
Homepage URL
zen.watanabe.e8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 07 | 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
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071539
