UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062690 |
|---|---|
| Receipt number | R000071775 |
| Scientific Title | Study on the Effectiveness of PICSI |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/26 00:20:21 |
* 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
Study on the Effectiveness of Physiological Sperm Selection Using Hyaluronic Acid
Acronym
Study on the Effectiveness of PICSI
Scientific Title
Study on the Effectiveness of PICSI
Scientific Title:Acronym
Study 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 effectiveness of physiological intracytoplasmic sperm injection (PICSI), which selects mature sperm based on their ability to bind to hyaluronic acid, in patients with infertility requiring ICSI by assessing embryo development and pregnancy and delivery outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blastocyst formation rate
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
| Medicine | Maneuver |
Interventions/Control_1
On the day of oocyte retrieval, semen is prepared using the standard laboratory procedure. Sperm with hyaluronic acid-binding ability are then selected using a PICSI Dish and used for intracytoplasmic sperm injection (ICSI).
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
1. Patients undergoing infertility treatment at the Reproductive Endocrinology and Infertility Clinic of Tohoku University Hospital and receiving assisted reproductive technology (ART).
2. Patients indicated for intracytoplasmic sperm injection (ICSI).
3. Patients who have received sufficient explanation regarding the study and have voluntarily provided written informed consent to participate in the study and to bear the costs associated with PICSI.
4.Patients meeting at least one of the following criteria:
Failure to obtain good-quality embryos following conventional ICSI.
Difficulty in sperm selection based solely on morphology and motility due to asthenozoospermia, teratozoospermia, or other sperm abnormalities.
Couples with an older male partner.
5.Patients otherwise considered appropriate for PICSI by the principal investigator or study investigators.
Key exclusion criteria
1. Cases in which no motile sperm are identified.
2. Cases undergoing other sperm-selection techniques, such as ZyMOT or intracytoplasmic morphologically selected sperm injection (IMSI).
3. Cases using sperm surgically retrieved by techniques such as testicular sperm extraction (TESE) or microsurgical epididymal sperm aspiration (MESA).
4. Cases in which the female partner is 43 years of age or older at the time of treatment planning.
5. Cases in which no sperm motility is observed and motile sperm cannot be obtained without the use of agents such as pentoxifylline.
6. Patients considered unable to participate appropriately in the study because of psychiatric disease, psychiatric symptoms, or other relevant conditions.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Zen |
| Middle name | |
| Last name | Watanabe |
Organization
Tohoku university graduate school of medicine
Division name
Department of perinatology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177251
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 perinatology
Zip code
9808574
Address
1-1 Seiryomachi, Aoba-ward, Sendai, Miyagi, 980-8574 Japan
TEL
0227177251
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, 980-8575, Japan
Tel
022-717-8007
zen.watanabe.e8@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 | 09 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | 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 | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071775
