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 |
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.
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.
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.
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.
Japan |
Azoospermia
Obstetrics and Gynecology |
Others
YES
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.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
the pregnancy rate per cycles and miscarriage rate
Rate of preimplantation development
Rate of PLCZ1 mRNA decay,
Array CGH
Methylation profile
mRNA expression profile
Birth rate
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Gene | Maneuver |
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.
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.
20 | years-old | <= |
60 | years-old | > |
Male and Female
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.
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.
100
1st name | |
Middle name | |
Last name | Atsushi Tanaka |
Saint Mother Hospital
4-9-12, Orio Yahatanishi, Kitakyusyu, Fukuoka, JAPAN
093-601-2000
incho@stmother.com
1st name | |
Middle name | |
Last name | Atsushi Tanaka |
Saint Mother Hospital
4-9-12, Orio Yahatanishi, Kitakyusyu, Fukuoka, JAPAN
093-601-2000
incho@stmother.com
Saint Mother Hospital
None
Self funding
NO
セントマザー産婦人科医院(福岡県)
2016 | Year | 02 | Month | 03 | Day |
Unpublished
Open public recruiting
2016 | Year | 01 | Month | 17 | Day |
2016 | Year | 02 | Month | 04 | Day |
2016 | Year | 02 | Month | 03 | Day |
2016 | Year | 02 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023961