UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020860 |
|---|---|
| Receipt number | R000023961 |
| Scientific Title | Verification of the clinical usefulness and the safety of the egg activation by PLCZ1 mRNA injection after intracytoplasmic injection using round spermatids from azoospermic men. |
| Date of disclosure of the study information | 2016/02/03 |
| Last modified on | 2016/02/08 14:14:21 |
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Basic information
Public title
Verification of the clinical usefulness and the safety of the egg activation by PLCZ1 mRNA injection after intracytoplasmic injection using round spermatids from azoospermic men.
Acronym
Verification of the clinical usefulness and the safety of the egg activation by PLCZ1 mRNA injection after intracytoplasmic injection using round spermatids from azoospermic men.
Scientific Title
Verification of the clinical usefulness and the safety of the egg activation by PLCZ1 mRNA injection after intracytoplasmic injection using round spermatids from azoospermic men.
Scientific Title:Acronym
Verification of the clinical usefulness and the safety of the egg activation by PLCZ1 mRNA injection after intracytoplasmic injection using round spermatids from azoospermic men.
Region
| Japan |
Condition
Condition
Azoospermia
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
After round spermatid injection into the oocyte, egg activation is induced by PLCZ1 mRNA injection. To verify the clinical usefulness and the safety of egg activation method by PLCZ1 mRNA injection, compared to electric stimulation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the pregnancy rate per cycles and miscarriage rate
Key secondary outcomes
Rate of preimplantation development
Rate of PLCZ1 mRNA decay,
Array CGH
Methylation profile
mRNA expression profile
Birth rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Gene | Maneuver |
Interventions/Control_1
1)Oocyte collection for patient's wife is performed after ovarian stimulation.
2)Round spermatid injection into the oocyte is performed.
3) The number of examined oocytes is one when number of collected oocytes is less than 10, one to two when more than 10. After round spermatid injection, the egg is activated by electric stimulation or PLCZ1 mRNA injection to cause resumption of the second meiosis.
4) Before embryo transfer, a part of preimplantation embryo cells is collected and analysis(array CGH, single cell methylation analyses and DNA microarray)is conducted.
5) For preliminary examination, the unfertilized eggs are injected with PLCZ1 mRNA, and the decay of PLCZ1 mRNA and developmental rate are confirmed in vitro culture.
Interventions/Control_2
1) Round spermatid injection into the oocyte is performed.
2) Remaining oocytes, besides the ones to which PLCz1 is applied, are activated to develop further with electric stimulation.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who had consented to participate in this treatment and satisfied the following conditions.
1. The round spermatid is their most advanced spermatogenic cell.
2. Testicular spermatozoa are dead, have head anomalies or the elongating and elongated spermatids are degenerative.
3. The number of collected oocytes from wives of patients that meet 1, 2 criteria is over five.
Key exclusion criteria
1. In the case when even once a few spermatozoa have been found even if no spermatozoa are observed in other frequent analysis.
2. In the case when the possibility of obtaining round spermatids is near zero.
3. In the case when the surgical procedure for round spermatid collection is likely to deteriorate the patient's health.
4. In the case when the number of collected oocytes from patient's wife is less than five.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Saint Mother Hospital
Division name
Zip code
Address
4-9-12, Orio Yahatanishi, Kitakyusyu, Fukuoka, JAPAN
TEL
093-601-2000
incho@stmother.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Tanaka |
Organization
Saint Mother Hospital
Division name
Zip code
Address
4-9-12, Orio Yahatanishi, Kitakyusyu, Fukuoka, JAPAN
TEL
093-601-2000
Homepage URL
incho@stmother.com
Sponsor or person
Institute
Saint Mother Hospital
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
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
セントマザー産婦人科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 03 | 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
| 2016 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | 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
| 2016 | Year | 02 | Month | 03 | Day |
Last modified on
| 2016 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023961
