UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043586 |
|---|---|
| Receipt number | R000049772 |
| Scientific Title | Development and research of a new Xeno-free sperm cryopreservation reagent that prevents exacerbation of sperm DNA fragmentation |
| Date of disclosure of the study information | 2021/03/11 |
| Last modified on | 2025/11/17 10:39:28 |
* 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
Development and research of a new Xeno-free sperm cryopreservation reagent that prevents exacerbation of sperm DNA fragmentation
Acronym
SDF sperm cryopreservation
Scientific Title
Development and research of a new Xeno-free sperm cryopreservation reagent that prevents exacerbation of sperm DNA fragmentation
Scientific Title:Acronym
SDF sperm cryopreservation
Region
| Japan |
Condition
Condition
Infertility patients
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will develop a new Xeno-free cryopreservation solution that can be used clinically with the aim of improving the motility after thawing frozen sperm and reducing the rate of sperm DNA fragmentation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SDF rate of sperm after freezing and thawing
Key secondary outcomes
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Discarded Specimens after in vitro fertilization or semen test that which the total sperm concentration of raw semen is 20 million per ml or more and the motility rate is 30 percentage or more.
2) Discarded specimens with a motility rate of 80 percentage or more and a motile sperm count of 10000 per ml or more after treatment by density gradient centrifugation
3) 20 years and over
4) After sufficient informed consent to participate in this study, the patient's voluntary written consent has been obtained.
Key exclusion criteria
1) discarded sample that the total sperm concentration of the raw semen is less than 20 million per ml or the motility rate is less than 30 percentage.
2) Specimens to be discarded with a motility rate of less than 80 percentage after treatment by density gradient centrifugation or a motile sperm count of less than 10000 per ml
3) Specimens judged by the principal investigator / coordinator to be inappropriate for research
Target sample size
440
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Maezawa |
Organization
Mie univercity
Division name
Department of Obstetrics and Gynecology, Mie Hospital
Zip code
5148507
Address
2-174 Edobashi, Tsu, Mie
TEL
0592321111
tada-m@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Tachibana |
Organization
Mie university
Division name
Center of Advanced Reproductive Medicine , Mie Hospital
Zip code
5148507
Address
2-174 Edobashi, Tsu, Mie
TEL
0592321111
Homepage URL
fertility-repro@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie univercity
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie
Tel
0592321111
kk-sien@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 | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2073-4409/12/22/2585
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2073-4409/12/22/2585
Number of participants that the trial has enrolled
148
Results
CPLL lowers SDF after freeze-thaw.
CPLL reduces ROS or LPO and preserves MMP and motility.
CPLL and low-dose resveratrol further decreases SDF.
Results date posted
| 2025 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were 24 male partners of women undergoing fertility treatment.
Participant flow
After obtaining consent from infertility treatment patients, discarded specimens from semen analysis or following completion of in vitro fertilization will be used.
Adverse events
none
Outcome measures
1. Sperm DNA fragmentation rate (SDF): Measured by TUNEL assay after freezing and thawing.
2. Reactive oxygen species (ROS): ROS production within mitochondria and cytoplasm.
3. Lipid peroxidation (LPO): Marker of membrane lipid peroxidation using 4-HNE antibody.
4. Mitochondrial membrane potential (MMP): Mitochondrial function assessment via JC-1 staining.
5. Sperm motility rate: Assessment of motility rate after freezing and thawing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 03 | Month | 11 | 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=R000049772
