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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
