UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Embryo cyopreservation for fertility preservation in women with cancer and autoimmune disease.
Title of the study (Brief title)	Embryo cryopreservation for fertility preservation
Region	Japan

Condition
Condition	Cancer, Collagen disease
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of embryo cryopreservation for patients with cancer or autoimmune disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The influence on progression of primary disease and treatment delay
Key secondary outcomes

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	Medicine
Interventions/Control_1	We perform cryopreservation by vitrification for embryos produced by in vitro fertilization or intracytoplasmic sperm injection from patients before main treatment for primary disease.
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	20 years-old <=
Age-upper limit	43 years-old >
Gender	Female
Key inclusion criteria	Patients with cancer or autoimmune disease. Patients whose physicians of primary disease make a written request for fertility preservation. Patients who are expected long term survival.
Key exclusion criteria	Patients who have malignancy in their ovary. Patients whose cancer may be sensitive to hormones.
Target sample size	10

Research contact person
Name of lead principal investigator	Morio Sawada
Organization	Kyoto Prefectural University of Medicine
Division name	Department of obstetrics and gynecology
Address	Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL	075-251-5560
Email	mosawada@koto.kpu-m.ac.jp

Public contact
Name of contact person	Hiroyuki Okimura
Organization	Kyoto Prefectural University of Medicine
Division name	Department of obstetrics and gynecology
Address	Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
TEL	075-251-5560
Homepage URL
Email	h-okim@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 04 Month 24 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 24 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 24 Day
Last modified on	2017 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031072