UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study to prevent a thin endometrium in patients undergoing clomiphene citrate treatment
Title of the study (Brief title)	prevent a thin endometrium
Region	Japan

Condition
Condition	Infertility
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 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	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	patients who were given 50mg/day clomiphene citrate on days 5-9(standard treatment, control group)
Interventions/Control_2	patients who were given 25mg/day clomiphene citrate on days 5-9(half-dose group)
Interventions/Control_3	patients who were given 50mg/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 diagnosed as having a thin endometrium(<8mm) 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 nonsteroidial anti-inflammatory agents.
Target sample size	61

Research contact person
Name of lead principal investigator	akihisa takasaki
Organization	Saiseikai Shimonoseki General Hospital
Division name	Department of Obstetrics and Gynecology
Address	Yasuokacho 8-5-1, Shimonoseki, 759-6603 Japan
TEL	0832622300
Email	a-takasaki@simo.saiseikai.or.jp

Public contact
Name of contact person	akihisa takasaki
Organization	Saiseikai Shimonoseki General Hospital
Division name	Department of Obstetrics and Gynecology
Address	Yasuokacho 8-5-1, Shimonoseki, 759-6603 Japan
TEL	0832622300
Homepage URL
Email	a-takasaki@simo.saiseikai.or.jp

Sponsor
Institute	Saiseikai Shimonoseki General Hospital
Institute
Department

Funding Source
Organization	Saiseikai Shimonoseki General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 15 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 15 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009369