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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043585
Receipt No. R000049771
Scientific Title Efficacy evaluation study of sperm regulation method "Migris method" in in vitro fertilization
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/11

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Basic information
Public title Efficacy evaluation study of sperm regulation method "Migris method" in in vitro fertilization
Acronym Miglis IVF
Scientific Title Efficacy evaluation study of sperm regulation method "Migris method" in in vitro fertilization
Scientific Title:Acronym Miglis IVF
Region
Japan

Condition
Condition In vitro fertilized patient and her husband
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the correlation between Sperm DNA fragmentation (SDF) rate in discarded samples of patients of IVF who sibling sperm prepared by density gradient centrifugation (DGC) and Miglis methods and IVF outcome (number of mature oocytes, fertilized oocytes, good embryos and blastcysts, pregnancy, abortion, childbirth etc).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between SDF rate and IVF outcome
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 and Female
Key inclusion criteria 1) Female patients between the ages of 20 and 50 (20 and over for husbands)
2) A patient (wife) and her husband who are expected to collect multiple eggs
3) Patients with written consent to participate in the study
Key exclusion criteria 1) Female and male patients under the age of 20
2) IVF patients who could not use half of the sperms treated by the DGC method (+ Swim-up method) and the Migris method by in vitro fertilization.
3) Patients who are judged by the principal investigator / coordinator to be inappropriate for inclusion in the study
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Maezawa
Organization Mie univercity
Division name Department of Obstetrics and Gynecology, Mie Hospital
Zip code 5148507
Address 2-174 Edobashi, Tsu, Mie
TEL 059-232-1111
Email tada-m@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Takeuchi
Organization Mie univercity
Division name Department of Obstetrics and Gynecology, Graduate School of Medicine
Zip code 5148507
Address 2-174 Edobashi, Tsu, Mie
TEL 059-232-1111
Homepage URL
Email miglis-sdf@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie univercity
Institute
Department

Funding Source
Organization Menicon
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Clinical Research Ethics Review Committee of Mie University Hospital
Address 2-174 Edobashi, Tsu, Mie
Tel 0592321111
Email kk-sien@mo.medic.mie-u.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

Other administrative information
Date of disclosure of the study information
2021 Year 04 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
2021 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 03 Month 11 Day
Last modified on
2021 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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