UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009034 |
|---|---|
| Receipt number | R000010601 |
| Scientific Title | The influence of physical constitution, life-style and environmental factors on sex hormones and anti-müllerian hormone |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2013/11/07 20:34:05 |
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Basic information
Public title
The influence of physical constitution, life-style and environmental factors on sex hormones and anti-müllerian hormone
Acronym
Relationship between anti-müllerian hormone, life-style and environmental factors
Scientific Title
The influence of physical constitution, life-style and environmental factors on sex hormones and anti-müllerian hormone
Scientific Title:Acronym
Relationship between anti-müllerian hormone, life-style and environmental factors
Region
| Japan |
Condition
Condition
Sterility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for inadequate secretion factors of sex hormones and AMH.
Basic objectives2
Others
Basic objectives -Others
Indirect observation without intervention
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of serum AMH based on ages, presence of smoking, sterility, physical constitution, and nutritional status
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
| Not applicable |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a)women (under 40 yr) who have never been pregnant.
(b) women (under 40 yr) who are multiparous
(c)women under infertility treatment
(d)healthy men
(e)men under infertility treatment
Key exclusion criteria
(a)Irrelevant man by medical doctor
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Suzuki |
Organization
Juntendo University
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo 113-8421
TEL
+81-(0)3-3813-3111(3325)
f-mitsuo@zc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Honda |
Organization
Juntendo University
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo 113-8421
TEL
+81-(0)3-3813-3111(3325)
Homepage URL
yhonda@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Luvtelli Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sato Obstetrics Hospital
BECKMAN COULTER Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
下北沢病院（東京都）/Simokitazawa Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | 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
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Our observation is case-control study. We evaluate the level of serum AMH based on ages, presence of smoking, sterility, physical constitution, and nutritional status.
Management information
Registered date
| 2012 | Year | 10 | Month | 03 | Day |
Last modified on
| 2013 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010601
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
