UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029464 |
|---|---|
| Receipt number | R000033550 |
| Scientific Title | The evaluation for usefulness of serum AMH levels to predict ovulation in patients of primary ovarian insufficiency |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/04/16 20:22:55 |
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Basic information
Public title
The evaluation for usefulness of serum AMH levels to predict ovulation in patients of primary ovarian insufficiency
Acronym
The evaluation for usefulness of serum AMH levels to predict ovulation in patients of primary ovarian insufficiency
Scientific Title
The evaluation for usefulness of serum AMH levels to predict ovulation in patients of primary ovarian insufficiency
Scientific Title:Acronym
The evaluation for usefulness of serum AMH levels to predict ovulation in patients of primary ovarian insufficiency
Region
| Japan |
Condition
Condition
primary ovarian insufficiency
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for usefulness of serum AMH levels to predict ovulation in patients of primary ovarian insufficiency
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum concentrations of AMH, every menstruation cycle, for 6 cycles
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Measurement of serum AMH levels one time per menstruation cycle (total 6 cycles)
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
Primary ovarian insufficiency or menopause under age 40
Key exclusion criteria
without desire for having children
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoko Osuka |
Organization
Nagoya University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2261
akiwase@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoko Osuka |
Organization
Nagoya University School of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2261
Homepage URL
akiwase@med.nagoya-u.ac.jp
Sponsor or person
Institute
Obstetrics and Gynecology, Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Obstetrics and Gynecology, Nagoya University School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 07 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033550
