UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053075 |
|---|---|
| Receipt number | R000060563 |
| Scientific Title | Analysis of the Effect of Preconception Care on Male Fertility |
| Date of disclosure of the study information | 2023/12/12 |
| Last modified on | 2024/06/12 15:40:03 |
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Basic information
Public title
Analysis of the Effect of Preconception Care on Male Fertility
Acronym
Analysis of the Effect of Preconception Care on Male Fertility
Scientific Title
Analysis of the Effect of Preconception Care on Male Fertility
Scientific Title:Acronym
Male preconception care
Region
| Japan |
Condition
Condition
male infertility
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
As preconception care for men, lifestyle modification and nutritional dietary guidance that may affect male fertility will be provided. As a result, we will verify whether semen findings, oxidative stress in semen, sperm DNA fragmentation, or changes in the sperm epigenome are improved as male fertility, and clarify the significance of this care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Changes in semen findings, sORP, DFI, microRNA expression, and diet before and after lifestyle diet modification guidance and urologic intervention
Key secondary outcomes
1) Association of lifestyle and diet with primary endpoints; 2) Association of male factors with primary endpoints; 3) Correlation of primary endpoints with pregnancy rate, time to pregnancy, miscarriage rate, and live 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Lifestyle guidance and nutritional dietary guidance will be provided once at the time of registration.
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) Male patients who are 18 years of age or older at the time of consent
2) Patients who have visited Chiba University Hospital or Kameda IVF Clinic Makuhari with the intention of conception.
3) Patients who have received a thorough explanation of their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1) Patients undergoing treatment for any of the following diseases that may affect the results of the study; malignant tumors (including pre-existing), uncontrolled allergic diseases
2) Taking any of the following medications that may affect the study results; Salazopyrine, finasteride, dutasteride, other hormonal drugs, psychotropic drugs, SSRIs, SNRIs, methotrexate
3) Patients with azoospermia
4) Those who have undergone infertility treatment in the past
5) Those who have participated in other clinical trials within one month prior to obtaining consent
6) Other subjects who are deemed by the investigator to be inappropriate for the study (i.e., study implementation may increase the risk to study subjects or may not provide sufficient data)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Komiya |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Urology
Zip code
260-8670
Address
1-8-1 Inohana Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2134
komiya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Komiya |
Organization
Chiba University Hospital
Division name
Department of Urology
Zip code
260-8677
Address
1-8-1 Inohanam Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2134
Homepage URL
komiya@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kameda IVF Clinic Makuhari
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Bioethics Committee of Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043-222-7171
hsp-seimei@chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 12 | 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
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060563
