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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034558
Receipt No. R000039397
Scientific Title To clarify the safety and efficacy of oocyte cryopreservation for fertility preservation.
Date of disclosure of the study information 2018/10/19
Last modified on 2018/10/18

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Basic information
Public title To clarify the safety and efficacy of oocyte cryopreservation for fertility preservation.
Acronym To clarify the safety and efficacy of oocyte cryopreservation for fertility preservation.
Scientific Title To clarify the safety and efficacy of oocyte cryopreservation for fertility preservation.
Scientific Title:Acronym To clarify the safety and efficacy of oocyte 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 Safety of ovarian stimulation, oocyte pick up, and cryopreservation of oocytes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of ovarian stimulation, oocyte pick up, and cryopreservation of oocytes.
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
Maneuver
Interventions/Control_1 ovarian stimulation
oocyte pick up
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
15 years-old <=
Age-upper limit
40 years-old >
Gender Female
Key inclusion criteria 1)Patients with a possibility of decreasing ovarian function due to chemotherapy or radiation therapy for cancer treatment.
2)Unmarried women.
3)Women aged >15 and <40 years.
4)Women who wish for a baby.
5)Women who gave permission free from the cancer treatment doctor to perform oocyte preservation.
6)Patients who received adequate explanation (both verbal and written) and provided informed consent.
Key exclusion criteria Patients determined to be unsuitable for safe oocyte cryopreservation.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Aoki
Organization University of the Ryukyus
Division name Graduate School of Medical Science University of the Ryukyus
Zip code
Address 207 Uehara, Nishihara, Okinawa
TEL 098-895-3331
Email yoichi@med.u-ryukyu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Mekaru
Organization University of the Ryukyus
Division name Graduate School of Medical Science University of the Ryukyus
Zip code
Address 207 Uehara, Nishihara, Okinawa
TEL 098-895-3331
Homepage URL
Email f041252@med.u-ryukyu.ac.jp

Sponsor
Institute University of the Ryukyus
Institute
Department

Funding Source
Organization University of the Ryukyus
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
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
2018 Year 10 Month 19 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
2014 Year 05 Month 02 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 02 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
2018 Year 10 Month 18 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039397

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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