UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027116 |
|---|---|
| Receipt number | 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 22:29:53 |
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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
| Obstetrics 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
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
h-okim@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031072
