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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000038886
Receipt No. R000044342
Scientific Title Effect of thyroid dysfunction and autoimmunity on infertility
Date of disclosure of the study information 2019/12/14
Last modified on 2019/12/17

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Basic information
Public title Effect of thyroid dysfunction and autoimmunity on infertility
Acronym Infertility and thyroid dysfunction
Scientific Title Effect of thyroid dysfunction and autoimmunity on infertility
Scientific Title:Acronym Infertility and thyroid dysfunction
Region
Japan

Condition
Condition Infertility, Hypothyroidism, Hashimoto's disease
Classification by specialty
Endocrinology and Metabolism Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of thyroid dysfunction and autoimmunity on infertility
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fertility and pregnancy outcome
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
70 years-old >
Gender Female
Key inclusion criteria Women who admitted to a fertility clinic
Key exclusion criteria Malignancy and history of thyroid surgery
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Nishi
Organization Wakayama Medical University
Division name First Department of Internal Medicine
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama City, Wakayama
TEL 073-441-0625
Email mnishi@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Nishi
Organization Wakayama Medical University
Division name First Department of Internal Medicine
Zip code 641-8509
Address 811-1 Kimiidera, Wakayama City, Wakayama
TEL 073-441-0625
Homepage URL
Email mnishi@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Roche Diagnostics (Tokyo, Japan)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Wakayama Medical University Ethics Committee
Address 811-1 Kimi-idera, Wakayama
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 12 Month 14 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 595
Results
The test had already finished.
Results date posted
2019 Year 12 Month 17 Day
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
2013 Year 01 Month 01 Day
Date of IRB
2013 Year 03 Month 28 Day
Anticipated trial start date
2013 Year 03 Month 28 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyse results and try to publish

Management information
Registered date
2019 Year 12 Month 14 Day
Last modified on
2019 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044342

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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