UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043585
Receipt number 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 2021/06/17 20:49:31

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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

Obstetrics 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 or person

Institute

Mie univercity

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 30 Day

Date of IRB

2020 Year 12 Month 16 Day

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 06 Month 17 Day



Link to view the page

Value
https://center6.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