UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053294 |
|---|---|
| Receipt number | R000060826 |
| Scientific Title | An exploratory study of methylenetetrahydrofolate reductase (MTHFR) gene polymorphism frequencies in men and women of reproductive age |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/01/09 10:57:30 |
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Basic information
Public title
An exploratory study of methylenetetrahydrofolate reductase (MTHFR) gene polymorphism frequencies in men and women of reproductive age
Acronym
An exploratory study of methylenetetrahydrofolate reductase (MTHFR) gene polymorphism frequencies in men and women of reproductive age
Scientific Title
An exploratory study of methylenetetrahydrofolate reductase (MTHFR) gene polymorphism frequencies in men and women of reproductive age
Scientific Title:Acronym
An exploratory study of methylenetetrahydrofolate reductase (MTHFR) gene polymorphism frequencies in men and women of reproductive age
Region
| Japan |
Condition
Condition
Reproductive age Men and women suspected of infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore genotype frequencies of the following MTHFR genotypes in men and women of reproductive age and determine their impact on reproductive function test items.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
genotype frequencies of the following MTHFR genotypes in men and women of reproductive age
Key secondary outcomes
Male:
Semen analysis (semen volume, sperm concentration, motility), semen oxidation-reduction potential (sORP test), sperm DNA fragmentation index test (sperm DFI test)
History of urological diseases and surgeries at the time of interview, sexual desire and sexual intercourse, SHIM diagnostic test results, etc.
Measurement of serum folate and homocysteine
Women
Menstrual estrogen, progesterone, LH, FSH, PRL, AMH, etc.
Results of questionnaires on menstruation, pregnancy, medications/medical history, surgical history, infertility treatment history, etc. at the time of interview
Serum folate and homocysteine levels
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. have been fully informed of the purpose and content of the study, have the capacity to consent, and have volunteered to participate of their own free will with full understanding, and have agreed to participate in writing
2. Men and women must be at least 20 years of age at the time of participation.
Key exclusion criteria
Those deemed ineligible at the discretion of the principal investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Kawai |
Organization
Kameda IVF Clinic MAKUHARI
Division name
reproductive medicine
Zip code
2618501
Address
1-3D3F Nakase Mihama-ku Ciba-city Chiba Japan
TEL
81-43-296-8141
kawai.kiyotaka@kameda.jp
Public contact
Name of contact person
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Kawai |
Organization
Kameda IVF Clinic MAKUHARI
Division name
Reproductive medicine
Zip code
26108501
Address
1-3D3F Nakase Mihama-ku Ciba-city Chiba Japan
TEL
81-43-296-8141
Homepage URL
kawai.kiyotaka@kameda.jp
Sponsor or person
Institute
Kameda IVF Clinic Makuhari
Institute
Department
Personal name
Funding Source
Organization
none
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
Kameda General Hospital
Address
929 Higashi-cho Kamogawa-city Chiba Japan
Tel
81470922211
kawai.kiyotaka@kameda.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
| 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060826
