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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043586
Receipt No. 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 2021/03/11

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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
Obsterics 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
Email 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
Email fertility-repro@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie univercity
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2024 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
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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