UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007288 |
|---|---|
| Receipt number | R000008595 |
| Scientific Title | A pilot study to prevent a thin endometrium in patients undergoing clomiphene citrate treatment |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2012/02/14 13:27:01 |
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Basic information
Public title
A pilot study to prevent a thin endometrium in patients undergoing clomiphene citrate treatment
Acronym
clomiphene and thin endometrium
Scientific Title
A pilot study to prevent a thin endometrium in patients undergoing clomiphene citrate treatment
Scientific Title:Acronym
clomiphene and thin endometrium
Region
| Japan |
Condition
Condition
A prospective Randomized Controlled Trial.
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent a thin endometrium in patients undergoing clomiphene citrate (CC) treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endometrial thickness at the induction of ovulation was assessed by ultrasonography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
patients who received a standard clomiphene citrate treatment on days 5-9 (control group)
Interventions/Control_2
patients who were given 25 mg/day clomiphene citrate on days 5-9 (half-dose group)
Interventions/Control_3
patients who were given 50 mg/day clomiphene citrate on days 1-5 (early administration group)
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
patients who were diagnosed as having a thin endometrium (< 8 mm) during the standard clomiphene citrate treatment cycle were recruited in this study.
Key exclusion criteria
patients were excluded if they had myoma, adenomyosis, congenital uterine anomaly, or ovarian tumors. Patients were also excluded if they used estrogens, progesterone, androgens, or had chronic use of any medication, including nonsteroidal anti-inflammatory agents.
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Sugino |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Minamikogushi 1-1-1, Ube, 755-8505 Japan
TEL
+81-836-22-2288
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tamura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Minamikogushi 1-1-1, Ube, 755-8505 Japan
TEL
+81-836-22-2288
Homepage URL
hitamura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from the Ministry of Education, Science, and Culture, Japan
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 02 | Month | 15 | 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
Suspended
Date of protocol fixation
| 2012 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 14 | Day |
Last modified on
| 2012 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008595
