UMIN-CTR Clinical Trial

Basic information
Public title	Sperm cryopreservation for fertility-preservation in young male cancer patients, hematopoietic cell transplantation recipients and immune disease patients
Acronym	Sperm cryopreservation for fertility-preservation
Scientific Title	Sperm cryopreservation for fertility-preservation in young male cancer patients, hematopoietic cell transplantation recipients and immune disease patients
Scientific Title:Acronym	Sperm cryopreservation for fertility-preservation
Region	Japan

Condition
Condition	Cancer patient including hematological malignancy, autoimmune disease such as SLE
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Endocrinology and Metabolism Hematology and clinical oncology Nephrology Clinical immunology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Pediatrics Orthopedics Urology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verification of the effectiveness and safety in sperm cryopreservation as a clinical study for a fertility-preservation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sperm count and motility (before and after cryopreservation)
Key secondary outcomes	Fertilization rate, Live birth rate Influence of primary disease, treatment, patient's age and complications on sperm reserve and endocrine function after treatment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	sperm collection (ejaculated sperm) for cryopreservation
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients at risk of impairment of spermatogenesis due to treatment for cancer or immune disease. Expected long-term survival After puberty
Key exclusion criteria	Patients who do not agree to participate in this study Patients whom the start of therapy delays due to this study Patients who are judged to be ineligible for this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Mandai
Organization	Graduate school of medicine, Kyoto University
Division name	Department of obstetrics and gynecology
Zip code	606-8507
Address	Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
TEL	075-751-3269
Email	mandai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Akihito Middle name Last name Horie
Organization	Graduate school of medicine, Kyoto University
Division name	Department of obstetrics and gynecology
Zip code	606-8507
Address	Kawaharacho 54, Sho-goin, Sakyo-ku, Kyoto
TEL	075-751-3269
Homepage URL
Email	a_horie@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Self funding
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 20 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	Enrolling by invitation
Date of protocol fixation	2018 Year 09 Month 21 Day
Date of IRB	2019 Year 03 Month 18 Day
Anticipated trial start date	2019 Year 03 Month 18 Day
Last follow-up date	2034 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 20 Day
Last modified on	2020 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039022