UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of ovarian stimulation using ultra low dose rhFSH for unexplained infertility
Title of the study (Brief title)	Evaluation of ovarian stimulation using ultra low dose rhFSH for unexplained infertility
Region	Japan

Condition
Condition	unexplained infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluated the safety and usefulness of the rhFSH treatment for women with unexplained infertility
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentages of OHSS, multiple pregnancy, and hormone values
Key secondary outcomes	Pregnancy rate

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	rhFSH
Interventions/Control_2	without rhFSH
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	35 years-old >=
Gender	Female
Key inclusion criteria	1.Normal regular menstruation 2.Normal hormone range 3.Normal BMI
Key exclusion criteria	Nothing
Target sample size	120

Research contact person
Name of lead principal investigator	Atsushi Fukui
Organization	Hirosaki University
Division name	Obstetrics and Gynecology
Address	5 Zaifu-cho, Hirosaki
TEL	0172-39-5107
Email	atsushi@hirosaki-u.ac.jp

Public contact
Name of contact person	Atsushi Fukui
Organization	Hirosaki University
Division name	Obstetrics and Gynecology
Address	5 Zaifu-cho, Hirosaki
TEL	0172-39-5107
Homepage URL
Email	atsushi@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Nothing
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	2014 Year 05 Month 14 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 03 Day
Anticipated trial start date	2013 Year 05 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	2014 Year 05 Month 14 Day
Last modified on	2016 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016261