UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035723
Receipt number R000039241
Scientific Title Survey of fertility preservation treatment for children and adolescents with severe medical indication in Asia.
Date of disclosure of the study information 2019/01/31
Last modified on 2020/08/01 15:07:21

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Basic information

Public title

Survey of fertility preservation treatment for children and adolescents with severe medical indication in Asia.

Acronym

Fertility preservation for children in Asia.

Scientific Title

Survey of fertility preservation treatment for children and adolescents with severe medical indication in Asia.

Scientific Title:Acronym

Fertility preservation for children in Asia.

Region

Japan Asia(except Japan)


Condition

Condition

Malignant disease, hematological disease, collagen disease, immunological disease, ssysteminc disease

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to investigate the current state of fertility preservation treatment for children and adolescents, for generalization of Oncofertility.

Basic objectives2

Others

Basic objectives -Others

We aim to investigate the factors which influence the performing fertility preservation, in terms of economics and/or religious and/of cultual factors.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The numbers of hospitals could perform fertility preservation for child and adolescent patients? The kind of fertility preservation treaetment which is performed on each coutries.

Key secondary outcomes

Comparing with adult patients, has Fertility preservation treatment been treated for children and adolescents? And the reason why?


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


Not applicable

Age-upper limit

20 years-old >

Gender

Male and Female

Key inclusion criteria

Current status of fertility preservation for child and adolescent patients.

Key exclusion criteria

N/A

Target sample size

15


Research contact person

Name of lead principal investigator

1st name NAO
Middle name
Last name SUZUKI

Organization

St. Marianna University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN

TEL

044-977-8111

Email

nao@marianna-u.ac.jp


Public contact

Name of contact person

1st name SEIDO
Middle name
Last name TAKAE

Organization

St. Marianna University School of Medicine

Division name

Obstetrics and Gynecology

Zip code

216-8511

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN

TEL

044-977-8111

Homepage URL


Email

s2takae@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

N/A

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

IRB of St. Marianna University

Address

2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, JAPAN

Tel

044-977-8111

Email

k-sienbu.mail@marianna-u.ac.jp


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

2019 Year 01 Month 31 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/31681163/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/31681163/

Number of participants that the trial has enrolled

11

Results

In Asian countries, fertility preservation(FP) for children is not so popular than adult cases. The reason is mainly collboration issue among pediatricians and unfamilier medical stuffs.Also, almost of countries, doesn't have explanataion tools about FP for children.

Results date posted

2020 Year 08 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Representative person of ASFP on each countries

Participant flow

Invited using email

Adverse events

N/A

Outcome measures

Status of FP for adult patients,
Status of FP for child patients,
The barriers of FP for child patients,
The exixtence of explanation tool of FP for children.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 10 Month 18 Day

Date of IRB

2018 Year 10 Month 31 Day

Anticipated trial start date

2018 Year 10 Month 31 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 06 Month 30 Day


Other

Other related information

We already published the present study on Frontier in Endocrinology(PMID 31681163)


Management information

Registered date

2019 Year 01 Month 30 Day

Last modified on

2020 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039241


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name