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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034096
Receipt No. R000038874
Scientific Title A survey on menstrual re-start after GnRH agonist therapy for young women with cancer and autoimmune diseases
Date of disclosure of the study information 2018/09/12
Last modified on 2020/03/18

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Basic information
Public title A survey on menstrual re-start after GnRH agonist therapy for young women with cancer and autoimmune diseases
Acronym A survey on menstrual re-start after GnRH agonist therapy for young women with cancer and autoimmune diseases
Scientific Title A survey on menstrual re-start after GnRH agonist therapy for young women with cancer and autoimmune diseases
Scientific Title:Acronym A survey on menstrual re-start after GnRH agonist therapy for young women with cancer and autoimmune diseases
Region
Japan

Condition
Condition Premature ovarian failure
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In GnRH analog therapy for protecting the ovary from chemotherapy,Criteria for selection of GnRH analog therapy for ovarian protection can be formulated by confirming the effectiveness and select the cases for which treatment is appropriate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We report the results after 4 weeks from the start of the survey.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old >=
Gender Female
Key inclusion criteria Patients who did not receive GnRH therapy for ovarian protection in young women who received chemotherapy in the past
Key exclusion criteria before meniscal
over 41 years old
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Mandai
Organization Kyoto University Graduate School of Medicine
Division name Department of Gynecology & Obstetrics
Zip code 6068507
Address Shogoin, Sakyoku, Kyoto, 606-8507, Japan
TEL 075-751-3267
Email mandai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Akihito
Middle name
Last name Horie
Organization Kyoto University Hospital
Division name Consultation support center
Zip code 606-8507
Address Shogoin, Sakyoku, Kyoto, 606-8507, Japan
TEL 075-751-4748
Homepage URL
Email ctsodan@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Department of Gynecology & Obstetrics
Institute
Department

Funding Source
Organization Kyoto University Graduate School of Medicine
Department of Gynecology & Obstetrics
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 Kyoto University Graduate School of Medicine Department Specified Clinical Trials Management Office
Address Shogoin, Sakyoku, Kyoto, 606-8507, Japan
Tel N/A
Email N/A

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 09 Month 12 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 12 Day
Last follow-up date
2019 Year 09 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational studies

Target registration period is 1991-2017.
We search for GnRH analog non-users with medical record of our hospital,and In case we can not obtain information with medical record, we call patients and do questionnaire surveys by letter.

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038874

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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