臨床研究等提出・公開システム

Date of registration	Oct. 09, 2024
Last modified on	Oct. 09, 2024
Trial ID	jRCT1040240102

Scientific Title	Single-Institution Study on the Effect of Centrifugation-Based Washing of Sperm Recovered by the MSS Method on Sperm DNA Fragmentation
Public Title	MSS (MSS)

Contact for Scientific Queries	Name	Takayama Erina
	Affiliation	Mie university Hospital
	Address	2-174 Edobashi, Tsu city, Mie 514-8507
	Telephone	+81-59-232-1111
	E-mail	erina-t@med.mie-u.ac.jp
Contact for Public Queries	Name	Uemura Midori
	Affiliation	Mie university Hospital
	Address	2-174 Edobashi, Tsu city, Mie 514-8507
	Telephone	+81-59-232-1111
	E-mail	uemura-m@med.mie-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 09, 2024
Target sample size		30
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Male patients aged 18 years or older 2) Patients whose background can be confirmed in the medical records 3) Patients who do not have azoospermia or severe oligospermia 4) Individuals who have provided written consent for participation in the study
	Exclusion Criteria	1) Patients whom the principal investigator or co-investigator deems inappropriate for inclusion in the study 2) In the case where the patient themselves requests to withdraw.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Male
Health Condition(s) or Problem(s) Studied		Male infertility
Health Condition(s) Keyword		MSS
Primary Outcome(s)		The comparison of SDF (Sperm DNA Fragmentation) values between raw semen, sperm processed by the MSS method, and sperm washed after being processed by the MSS method.
Secondary Outcome(s)		Age, total sperm count, sperm motility rate, odd-shaped sperm rate

Primary Sponsor	none

Name of Certified Review Board	the Clinical Research Ethics Review Committee of Mie University Hospital
Address	2-174 Edobashi, Tsu city, Mie 514-8507, Mie
Telephone	+81-59-231-5045
E-Mail	mie-crb@mo.medic.mie-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 08, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none