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

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 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


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

Value
https://center6.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