UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040355 |
|---|---|
| Receipt number | R000046050 |
| Scientific Title | Verification of the usefulness of Migration-Gravity Sedimentation Method as a sperm selection method from the viewpoint of sperm DNA Fragmentation |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2022/05/16 08:11:25 |
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Basic information
Public title
Evaluation of DNA damage in original sperm and sperm selected by each sperm preparation method
Acronym
Sperm DFI
Scientific Title
Verification of the usefulness of Migration-Gravity Sedimentation Method as a sperm selection method from the viewpoint of sperm DNA Fragmentation
Scientific Title:Acronym
Verification of the usefulness of the Miglis method from the viewpoint of SDF
Region
| Japan |
Condition
Condition
Male infertility in general
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of various semen treatment methods on SDF levels in male infertility patients subject to in vitro fertilization
Basic objectives2
Others
Basic objectives -Others
Measurement of total sperm concentration, motility, malformation rate of sperm before and after various sperm preparations, and amount of semen components mixed by metal protease assay kit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SDF values before and after each sperm preparation method
Key secondary outcomes
Total sperm concentration, motility, malformation rate, Zn + value of sperm before and after various sperm adjustments
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Age of 20 over
Patients with written informed consent to participate in the study
Key exclusion criteria
Waste sample with total sperm concentration of 1 million / mL or less
Discarded specimens with original semen motility of 10%
Patients who the investigator / co-investigator determined to be inappropriate for inclusion in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Maezawa |
Organization
Mie Univercity
Division name
Center of Advanced Reproductive Medicine, Mie Hospital
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie Prefecture
TEL
059-232-1111
fertility-repro@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takeuchi |
Organization
Mie Univercity
Division name
Department Obstetrics and Gynecology, Graduate School of Medicine
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie Prefecture
TEL
059-232-1111
Homepage URL
fertility-repro@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie Univercity
Institute
Department
Personal name
Funding Source
Organization
Menicon Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
HANABUSA WOMEN'S CLINIC
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 City, Mie Prefecture
Tel
059-232-111
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
三重大学病院（三重県）、英ウィメンズクリニック（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective, multicenter study comparing the raw semen of infertile patients and the sperm DNA damage rate after processing the raw semen after each sperm preparation method
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046050
