UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044332 |
|---|---|
| Receipt number | R000050574 |
| Scientific Title | Effect of COVID-19 mRNA Vaccine on Semen Parameters |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2021/11/24 13:39:12 |
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Basic information
Public title
Effect of COVID-19 mRNA Vaccine on Semen Parameters
Acronym
Effect of COVID-19 mRNA Vaccine on Semen Parameters
Scientific Title
Effect of COVID-19 mRNA Vaccine on Semen Parameters
Scientific Title:Acronym
Effect of COVID-19 mRNA Vaccine on Semen Parameters
Region
| Japan |
Condition
Condition
Male infertility
Classification by specialty
| Obstetrics and Gynecology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the effect of COVID-19 mRNA Vaccine on semen parameters among 20 male volunteers.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Semen Analysis
Time Frame:
1)Before the first mRNA COVID-19 vaccine (2 times)
2)2 weeks after the first COVID-19 vaccine (2 times)
3) 2 weeks after the second COVID-19 vaccine (2 times)
4) 4 weeks after the second COVID-19 vaccine (2 times)
* 2 days of abstinence period before semen collection
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. Male Volunteers
2. Ages 20-50
3. Unvaccinated at the time of enrollment. Vaccinate with the first and second Pfizer's COVID-19 Vaccine from May to December 2021.
4. Able to supply semen samples 8 times in total as scheduled.
5. Submission of signed informed consent with ability and willingness.
Key exclusion criteria
1.Taking medications that would interfere with semen analysis parameters.
2.History of COVID-19 infection at the time of enrollment.
3.Not eligible to receive COVID-19 mRNA vaccination due to health factors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL
06-6136-3344
tishikawa@reposaka.jp
Public contact
Name of contact person
| 1st name | Tomomoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Reproduction Clinic Osaka
Division name
Reproduction Clinic Osaka
Zip code
530-0011
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
TEL
06-6136-3344
Homepage URL
tishikawa@reposaka.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Reproduction Clinic Osaka Research Ethics Committee
Address
15F, Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-0011 Japan
Tel
06-6136-3401
htakizawa@reposaka.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
リプロダクションクリニック大阪（大阪府）/ Reproduction Clinic Osaka (Osaka)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 15 | 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 study comparing semen parameters among male volunteers aged 20-50, before and after receiving the first and second dose of Pfizer's COVID-19 vaccination. Currently, there is no medical and scientific information which evaluated semen parameters following the COVID-19 vaccination.
Management information
Registered date
| 2021 | Year | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050574
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
