UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014600
Receipt number R000016987
Scientific Title A prospective, randomized study to examine effectiveness of a novel micromanipulator (Venus, Vortex-like-movement-Evoked Nicking Upon Stick-site) for intra-cytoplasmic sperm injection (ICSI).
Date of disclosure of the study information 2014/07/20
Last modified on 2014/07/20 17:49:36

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Basic information

Public title

A prospective, randomized study to examine effectiveness of a novel micromanipulator (Venus, Vortex-like-movement-Evoked Nicking Upon Stick-site) for intra-cytoplasmic sperm injection (ICSI).

Acronym

Examination of effectiveness of a novel micromanipulator for ICSI (Venus, Vortex-like-movement-Evoked Nicking Upon Stick-site).

Scientific Title

A prospective, randomized study to examine effectiveness of a novel micromanipulator (Venus, Vortex-like-movement-Evoked Nicking Upon Stick-site) for intra-cytoplasmic sperm injection (ICSI).

Scientific Title:Acronym

Examination of effectiveness of a novel micromanipulator for ICSI (Venus, Vortex-like-movement-Evoked Nicking Upon Stick-site).

Region

Japan


Condition

Condition

Infertility treated by ICSI for severe male infertility or fertilization failure due to oocyte problem.

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We have invented a novel micromanipulator, Venus (Vortex-like-movement-Evoked Nicking Upon Stick-site), which enables an injection pipette to rotate while sticking like a gimlet. We examine effectiveness of Venus to improve ICSI outcomes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of embryonic development per injected oocyte.

Key secondary outcomes

The number of sticks until successful injection, the rate of survived oocyte per injected oocyte, and fertilization rate.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Subjects can freely decide to participate in the trial or not, and do not have any disadvantages when they do not participate. Informed consents are obtained from all participants after they have received appropriate explanations about implications, purposes, methods, expected benefits, and possible risks of this study, and the protection of privacy.
In the subjects, retrieved oocytes are removed of cumulus cells by hyaluronidase treatment after preincubation and the extrusion of a first polar body is observed. ICSI is attempted into oocytes with a first polar body as follows. First, an injection pipette is stuck gently into an oocyte without penetration of membrane, making a dead-end tunnel. If this first stick causes membrane penetration, the oocytes are categorized as the direct routine (DR) group, which usually represent poor quality oocytes. In majority of normal quality oocytes, the first gentle stick does not cause penetration, making a dead-end tunnel. Then, the pipette is retracted and penetrated into the oocyte through the side-wall of the tunnel either using the Venus (the side-wall Venus [SV] group) or not (the routine [R] group). Oocytes are allocated into either of the SV or R group prospectively and at random. If the second side-wall stick does not penetrate oocyte membrane, the same procedure is repeated in the opposite side-wall of the tunnel in the both groups (the third stick). If the third stick fail to penetrate, oocyte position is changed and the same procedures from the first stick until the third stick are repeated.
If the second stick penetrates oocyte membrane before actually starting Venus after allocation into the SV group, the oocytes are recategorized as the SV-unintended routine (SV-UR) group.
The number of sticks, survival rate, fertilization rate, and embryonic development are compared among 4 groups of DR, R, SV, and SV-UR, to confirm the effectiveness of the Venus.

Interventions/Control_2

The control group is the routine (R) group, as described above, in which oocyte membrane is penetrated by sticking the side-wall of the tunnel without Venus after the second stick.

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

39 years-old >=

Gender

Female

Key inclusion criteria

The study include patients who satisfy all the following criteria; (1) age = or < 39 years, (2) to undergo the first, second or third attempt of assisted reproductive technology (ART) therapy, (3) the number of retrieved oocytes are > or = 6, and (4) mainly severe male infertility (or infertility possibly due to anti-sperm antibody, hyperproduction of reactive oxygen species by sperm, or fertilization failure from oocyte factors).

Key exclusion criteria

Patients are excluded when they meet any of the following criteria; (1) diminished ovarian reserve (AMH < 2 ng/mL, day 3 FSH > 15 IU/L, or day 3 estradiol > 60 pg/mL, (2) non-obstructive azoospermia.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Jinno

Organization

Women's Clinic Jinno

Division name

Reproductive Medicine

Zip code


Address

3-1-39-201 Kokuryou-chou, Choufu City, Tokyo, Japan

TEL

042-480-3105

Email

mjinno@s9.dion.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masao Jinno

Organization

Women's Clinic Jinno

Division name

Reproductive Medicine

Zip code


Address

3-1-39-201 Kokuryou-chou, Choufu City, Tokyo, Japan

TEL

042-480-3105

Homepage URL


Email

mjinno@s9.dion.ne.jp


Sponsor or person

Institute

Women's Clinic Jinno

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

Kitazato Corporation

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization


Address


Tel


Email



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

ウィメンズクリニック神野(東京都)/ Women's Clinic Jinno (Tokyo)


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 20 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

2014 Year 07 Month 15 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 07 Month 20 Day

Last modified on

2014 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name