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

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 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


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

Value
https://center6.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