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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020860
Receipt No. 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

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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
Obsterics 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
Email 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
Email incho@stmother.com

Sponsor
Institute Saint Mother Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023961

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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