UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053455 |
|---|---|
| Receipt number | R000061001 |
| Scientific Title | Relative quantitative analysis of sperm protein expression in cases of fertilization failure by Liquid Chromatograph-Mass Spectrometry ( LC-MS/MS) |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2026/01/06 14:17:55 |
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Basic information
Public title
Relative quantitative analysis of sperm protein expression in cases of fertilization failure by Liquid Chromatograph-Mass Spectrometry ( LC-MS/MS)
Acronym
Analysis of sperm protein expression in cases of fertilization failure by Liquid Chromatograph-Mass Spectrometry ( LC-MS/MS)
Scientific Title
Relative quantitative analysis of sperm protein expression in cases of fertilization failure by Liquid Chromatograph-Mass Spectrometry ( LC-MS/MS)
Scientific Title:Acronym
Analysis of sperm protein expression in cases of fertilization failure by Liquid Chromatograph-Mass Spectrometry ( LC-MS/MS)
Region
| Japan |
Condition
Condition
Infertility with recognized fertilization failure
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will try to isolate proteins related to human fertilization failure by analyzing the expression profile of sperm proteins in infertile patients with fertilization failure and the amount of expression by mass spectrometry. In addition, the results obtained from this research may lead to the elucidation of the cause of fertilization failure.
Basic objectives2
Others
Basic objectives -Others
The results obtained from this research may not only lead to the elucidation of the cause of fertilization failure, but also lead to the development of new prevention methods, accurate diagnosis of patients, and treatments in the future.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
In comparing the amount of protein expression by mass spectrometry, for the expected ratio of less than 0.2 times and more than 1.8 times, the confidence level is 95% and the interval width is 0.05.
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
| 43 | years-old | > |
Gender
Female
Key inclusion criteria
1) In vitro fertilization has a fertilization rate of 50% or more
2) Fertilization rate of less than 50% for in vitro fertilization and more than 50% for ICSI
3) Fertilization rate less than 50% with in vitro fertilization and less than 50% fertilization rate with ICSI
Key exclusion criteria
In the case of a diagnosis of azoospermia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | none |
| Last name | Yamaguchi |
Organization
YamaguchiART Clinic
Division name
Reproduction
Zip code
370-0831
Address
257 Dainogo-cho Ota City Gunma Pre Japan
TEL
0276-45-8818
takabonver62@hotmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | none |
| Last name | Yamaguchi |
Organization
Yamaguchi ART Clinic
Division name
Reproduction
Zip code
373-0801
Address
257 Dainogo-cho Ota City Gunma Pre Japan
TEL
0276-45-8818
Homepage URL
takabonver62@hotmail.com
Sponsor or person
Institute
Yamaguchi ART Clinic
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi ART Clinic
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
Sato hospital
Address
96 Wakamatu cho Takasaki city Gunma Pre Japan
Tel
027-322-2243
takabonver62@hotmail.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
高崎ARTクリニック(群馬県)、山口ARTクリニック(群馬県)、浜松医科大学(静岡県)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | 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
| Delay expected |
Results Delay Reason
This study is an observational study that uses only existing samples and information obtained during routine medical care and does not involve any invasive procedures or interventions. To date, analyses have been completed for 41 cases; however, it was determined that an extension of the study period is necessary in order to achieve the originally planned target sample size and to adequately conduct inter-group comparative and exploratory analyses.
This change consists solely of an extension of the study period (from March 31, 2026, to March 31, 2027). There are no changes to the study design, research methods, analytical methods, inclusion or exclusion criteria for research subjects, level of invasiveness, informed consent procedures, or the handling of personal information.
For the reasons stated above, we hereby apply for approval to extend the study period by one year.
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
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational research
Management information
Registered date
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061001
