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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014600
Receipt No. 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

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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
Obsterics 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
Last 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
1st 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
Institute Women's Clinic Jinno
Institute
Department

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
URL(English) https://upload.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


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