UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031791 |
|---|---|
| Receipt number | R000036288 |
| Scientific Title | Development of new sperm freezing method |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2025/11/17 10:21:12 |
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Basic information
Public title
Development of new sperm freezing method
Acronym
sperm freezing method
Scientific Title
Development of new sperm freezing method
Scientific Title:Acronym
sperm freezing method
Region
| Japan |
Condition
Condition
Male infertility
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Focusing on osmotic pressure adjustment (saccharides), intracellular and extracellular freezing agents and freezing methods, we aim to newly study sperm freezing and thawing, with the aim of improving the survival rate after sperm freezing and thawing.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival rate of sperm after freezing and thawing.
Key secondary outcomes
Mortality, malformation rate, motility of sperm after freezing and thawing.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
Specimen to be discarded which has a motion sperm ratio of more than 60% after treatment by density gradient centrifugation.
Age; 20 years old and over.
Document consent was obtained with free will of the patient himself after sufficient informed consent to participate in this research.
Key exclusion criteria
Waste specimens with an exercise rate of original semen of 30% or less.
Specimens to be discarded with motion sperm ratio of less than 60% after treatment by density gradient centrifugation.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Mikiko |
| Middle name | |
| Last name | Nishioka |
Organization
Mie University Hosptal
Division name
Center for Advanced reproductive medical
Zip code
514-8507
Address
2-174 Edobashi, Tsu city, Mie prefecture
TEL
059-232-1111
tada-m@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Higashimoto |
Organization
Mie University Hosptal
Division name
Center for Advanced reproductive medical
Zip code
514-8507
Address
2-174 Edobashi, Tsu city, Mie prefecture
TEL
059-232-1111
Homepage URL
k-seisyoku@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hosptal
Institute
Department
Personal name
Funding Source
Organization
Mie 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
Medical Research Ethics Committee, Mie University Hospital
Address
2-174 Edobashi, Tsu city, Mie prefecture
Tel
059-232-1111
s-kenkyu@mo.medic.mie-u.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
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2073-4409/10/6/1435
Number of participants that the trial has enrolled
105
Results
The xeno-free cryoprotectant (Gly + CPLL + saccharide) achieved post-thaw motility, viability, and DNA fragmentation comparable to a commercial albumin-containing reagent.
CPLL was an effective macro-CPA and glycerol 7% was optimal as a low-molecular CPA.
Saccharide supplementation was essential for maintaining post-thaw motility.
Results date posted
| 2025 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Semen samples from 105 male infertility patients at a university hospital.
Participant flow
After obtaining consent, discarded specimens from semen analysis or in vitro fertilization
Adverse events
none
Outcome measures
Post-thaw sperm motility, viability, and DNA fragmentation.
Capacitation status and acrosome reaction.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 17 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 17 | Day |
Other
Other related information
prospective, observational study
Management information
Registered date
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036288
