UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030904
Receipt number R000035277
Scientific Title Comparing clinical efficacy of the media from human tubal fluid to the media currently used.
Date of disclosure of the study information 2018/01/22
Last modified on 2022/07/27 13:29:36

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Basic information

Public title

Comparing clinical efficacy of the media from human tubal fluid to the media currently used.

Acronym

Comparing clinical efficacy of the media from human tubal fluid to the media currently used.

Scientific Title

Comparing clinical efficacy of the media from human tubal fluid to the media currently used.

Scientific Title:Acronym

Comparing clinical efficacy of the media from human tubal fluid to the media currently used.

Region

Japan


Condition

Condition

Infertility

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To get knowledge whether a new media for embryo bring about same or better outcome compare with conventional media

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Compere the pregnancy rate following embryo transfer after using new media to using conventional media.

Key secondary outcomes

Observe the condition in embryo development, and obtain the rate of efficacy embryo between the two media.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Culture and transfer embryos using the new media by June, 2020

Interventions/Control_2

Culture and transfer embryos using the conventional media by December, 2025

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


Not applicable

Age-upper limit

45 years-old >=

Gender

Female

Key inclusion criteria

Use embryos for this study only when normal fertilization is obtained after in vitro fertilization.

Key exclusion criteria

When none of normal embryos obtained, it is excluded from this study.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Takafumi
Middle name
Last name Utsunomiya

Organization

St. Luke Clinic

Division name

Doctor

Zip code

87010823

Address

1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan

TEL

097-547-1234

Email

st-luke@oct-net.ne.jp


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Kumasako

Organization

St. Luke clinic

Division name

Laboratory

Zip code

8700823

Address

1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan

TEL

097-547-1234

Homepage URL


Email

ykumasa@st-luke.jp


Sponsor or person

Institute

St. Luke clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Luke clinic Ethics Committee

Address

1-4-5, Higashi-Omichi, Oita-shi, Oita-ken, Japan

Tel

0975471234

Email

st-luke@oct-net.ne.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

セント・ルカ産婦人科(大分県)


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 22 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

Completed

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB

2017 Year 09 Month 19 Day

Anticipated trial start date

2017 Year 09 Month 19 Day

Last follow-up date

2022 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 20 Day

Last modified on

2022 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name