UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038886 |
|---|---|
| Receipt number | 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 21:55:51 |
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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 | Obstetrics 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
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
mnishi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044342
