臨床研究等提出・公開システム

Date of registration	April. 01, 2025
Last modified on	April. 17, 2025
Trial ID	jRCT1060240142

Scientific Title	Evaluation of preimplantation genetic testing for aneuploidy ver1.
Public Title	Evaluation of preimplantation genetic testing

Contact for Scientific Queries	Name	Iwasa Takeshi
	Affiliation	Tokushima University Hospital
	Address	3-18-15, Kuramoto-cho, Tokushima city, Tokushima
	Telephone	+81-88-633-7177
	E-mail	iwasa.takeshi@tokushima-u.ac.jp
Contact for Public Queries	Name	Iwasa Takeshi
	Affiliation	Tokushima University Hospital
	Address	3-18-15, Kuramoto-cho, Tokushima city, Tokushima
	Telephone	+81-88-633-7177
	E-mail	iwasa.takeshi@tokushima-u.ac.jp

Recruitment status	Pending


Anticipated date of first enrollment		April. 01, 2025
Target sample size		383
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Reccurent implantation failure 2. Reccurent abortion 3. Chromosomal reaarangement
	Exclusion Criteria	Health problems avoiding pregnancy
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Infertility
Intervention(s)		Several cells are biopsied from embryos, and chromosomal status is evaluated. Based on the results, embryos transferred is selected.
Health Condition(s) Keyword		infertility, IVF, PGT
Health Condition(s) Code		D007246
Intervention(s) Code		D019836
Primary Outcome(s)		Ongoing pregnancy at 12wk.
Secondary Outcome(s)		Misscarriage rate Implantation rate Clinical pregnancy rate Pregnancy rate at first OPU cycle

Primary Sponsor	Sysmex Corporation

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	The Ethics Committee of Tokushima University Hospital
Address	50-1, Kuramoto-cho, Tokushima city, Tokushima, Tokushima
Telephone	+81-88-633-9294
E-Mail	crb@tokushima-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 17, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 17, 2025	(this page)	Changes
1	April. 01, 2025	Detail

List of change history