UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006117 |
|---|---|
| Receipt number | R000007234 |
| Scientific Title | Verification of the clinical usefulness and the safety of the treatment of azoospermic men using round spermatids. |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2011/12/12 13:59:21 |
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Basic information
Public title
Verification of the clinical usefulness and the safety of the treatment of azoospermic men using round spermatids.
Acronym
Verification of the clinical usefulness and the safety of the treatment of azoospermic men using round spermatids.
Scientific Title
Verification of the clinical usefulness and the safety of the treatment of azoospermic men using round spermatids.
Scientific Title:Acronym
Verification of the clinical usefulness and the safety of the treatment of azoospermic men using round spermatids.
Region
| Japan |
Condition
Condition
Azoospermia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the clinical usefulness and the safety of the round spermatid injection into the oocyte.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the pregnancy rate per cycles and miscarriage rate
Key secondary outcomes
Birth rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Round spermatid injection into the oocyte is performed in much the same way as that with using elongating spermatids.
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
The patients who had consented to participate in this treatment and satisfied the following conditions.
1. The round spermatid is the most advanced spermatogenic cell.
2. Testicular spermatozoa are dead, have head anomalies or the elongating and elongated spermatids are degenerative.
Key exclusion criteria
1. In the case when quite a few spermatozoa have been found even if no spermatozoa were observed in frequent analysis.
2. In the case when the possibility of obtaining round spermatids is near zero.
3. In the case when the surgical procedure for round spermatid collection is likely to deteriorate the patient's health.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Saint Mother Clinic
Division name
Zip code
Address
4-9-12 Orio Yahatanishi Kitakyushu, Fukuoka, JAPAN
TEL
093-601-2000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Saint Mother Clinic
Division name
Zip code
Address
4-9-12 Orio Yahatanishi Kitakyushu, Fukuoka, JAPAN
TEL
093-601-2000
Homepage URL
incho@stmother.com
Sponsor or person
Institute
Saint Mother Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
セントマザー産婦人科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 04 | Day |
Last modified on
| 2011 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007234
