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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000007288
Receipt No. 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

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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 Obsterics 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
Email

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
Email hitamura@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008595

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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