UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055045 |
|---|---|
| Receipt number | R000062867 |
| Scientific Title | A retrospective observational study on the outcomes of Epididymal Tail Sperm Collection for Male Infertility Caused by Spinal Cord Injury |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/22 18:01:18 |
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Basic information
Public title
A retrospective observational study on the outcomes of Epididymal Tail Sperm Collection for Male Infertility Caused by Spinal Cord Injury
Acronym
The outcomes of Epididymal Tail Sperm Collection for Male Infertility Caused by Spinal Cord Injury
Scientific Title
A retrospective observational study on the outcomes of Epididymal Tail Sperm Collection for Male Infertility Caused by Spinal Cord Injury
Scientific Title:Acronym
A retrospective observational study on the outcomes of Epididymal Tail Sperm Collection for Male Infertility Caused by Spinal Cord Injury
Region
| Japan |
Condition
Condition
Azoospermia, spinal cord injury
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have discovered that sperm can be retrieved from the epididymis tale for male infertility due to spinal cord injury, and have been performing in vitro fertilization. The purpose of this study is to retrospectively observe the method and treatment outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
collected sperm rate from epididymal tail sperm collection for male infertility caused by spinal cord injury
Key secondary outcomes
ROC analysis of predicted FSH values for which Epididymal Tail Sperm can be retrieved
Pregnancy rate using Epididymal Tail Sperm
Birth rate using Epididymal Tail Sperm
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
| 25 | years-old | <= |
Age-upper limit
| 51 | years-old | >= |
Gender
Male
Key inclusion criteria
A male infertility patient who is completely paralyzed due to spinal cord injury and is unable to ejaculate on his own
Key exclusion criteria
Patients who did not consent to surgery
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | yuya |
| Middle name | |
| Last name | Makino |
Organization
Saint Mother Clinic
Division name
Gynecology
Zip code
8070825
Address
4-9-12, Orio, Yahatanishiku, Kitakyushu city, Fukuoka prefecture
TEL
0936012000
y.makino.fn@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Makino |
Organization
Saint Mother Clinic
Division name
Gynecology
Zip code
8070825
Address
4-9-12, Orio, Yahatanishiku, Kitakyushu city, Fukuoka prefecture
TEL
0936012000
Homepage URL
soumu@stmother.com
Sponsor or person
Institute
Saint Mother Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
Saint Mother Clinic
Address
4-9-12, Orio, Yahatanishiku, Kitakyushu city, Fukuoka prefecture
Tel
0936012000
soumu@stmother.com
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
| 2024 | Year | 07 | Month | 22 | 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
176
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
Completed
Date of protocol fixation
| 1996 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 1996 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study of the outcomes of cauda epididymal sperm retrieval and subsequent assisted reproductive technology in male infertility patients with spinal cord injury
Management information
Registered date
| 2024 | Year | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062867
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
