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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027116
Receipt No. R000031072
Scientific Title Embryo cyopreservation for fertility preservation in women with cancer and autoimmune disease.
Date of disclosure of the study information 2017/04/24
Last modified on 2017/07/27

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Basic information
Public title Embryo cyopreservation for fertility preservation in women with cancer and autoimmune disease.
Acronym Embryo cryopreservation for fertility preservation
Scientific Title Embryo cyopreservation for fertility preservation in women with cancer and autoimmune disease.
Scientific Title:Acronym 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
1st name
Middle name
Last name Morio Sawada
Organization Kyoto Prefectural University of Medicine
Division name Department of obstetrics and gynecology
Zip code
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
1st name
Middle name
Last name Hiroyuki Okimura
Organization Kyoto Prefectural University of Medicine
Division name Department of obstetrics and gynecology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Terminated
Date of protocol fixation
2017 Year 04 Month 24 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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