UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053508 |
|---|---|
| Receipt number | R000061067 |
| Scientific Title | Psychological counselling study for the couples with azoospermia after unsuccessful microdissection testicular sperm extraction |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/04/06 09:20:31 |
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Basic information
Public title
Psychological counselling study for azoospermia couple
Acronym
Psychological counselling study for azoospermia couple
Scientific Title
Psychological counselling study for the couples with azoospermia after unsuccessful microdissection testicular sperm extraction
Scientific Title:Acronym
AZ Counselling study
Region
| Japan |
Condition
Condition
Azoospermia
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the medical records of couples who underwent MD-TESE at our clinic and were unable to have their sperm extracted, and compare the status of referral to an assisted reproductive technology facility through sperm donation between couples who received the semi-structured psychological counselling and those who did not. We also examine the differences in the background of the couples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Referral to an assisted reproductive technology facility through sperm donation and receiving the psychological counselling.
Key secondary outcomes
Psychosocial status.
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All of the following three conditions must be met;
1) Patients who had MD-TESE at our hospital.
2) Partner present on the date of MD-TESE.
3) The patient and partner have never had children.
Key exclusion criteria
Patients who refused to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kouhei |
| Middle name | |
| Last name | Sugimoto |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
International Center for Reproductive Medicine
Zip code
3438555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, JAPAN
TEL
+81-48-965-2028
reprostudy@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Koizumi |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
International Center for Reproductive Medicine
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, JAPAN
TEL
+81-48-965-2028
Homepage URL
reprostudy@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Kouhei Sugimoto
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Saitama Medical Center
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama, JAPAN
Tel
+81-48-965-1111
reprostudy@dokkyomed.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
獨協医科大学埼玉医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://dept.dokkyomed.ac.jp/dep-k/shien/offer/files/23038.pdf
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
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observation study
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061067
| Research Plan | |
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| Registered date | File name |
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