UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Inositol treatment for polycystic ovary syndrome (PCOS): Systematic review and meta-analysis
Title of the study (Brief title)	Inositol treatment for PCOS
Region	Japan

Condition
Condition	polycystic ovary syndrome
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of inositol on outcome in PCOS.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Parameters of glucose metabolism Ovarian function
Key secondary outcomes	Serum sex hormone

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	All randomized controlled trial comparing inositol with placebo intake in PCOS are included in this study.
Key exclusion criteria	We exclude studies that is not report our primary and secondary outcomes. We also exclude studies that did not set appropriate control group, is review article and is not clinical study.
Target sample size	100

Research contact person
Name of lead principal investigator	Makoto Nakano
Organization	Yokohama University of Pharmacy
Division name	General Health Medical Center
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL	045-859-1300
Email	m.nakano@hamayaku.ac.jp

Public contact
Name of contact person	Kohsuke Hayamizu
Organization	Yokohama University of Pharmacy
Division name	Laboratory of Food Chemistry
Address	601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL	045-859-1300
Homepage URL
Email	k.hayamizu@hamayaku.ac.jp

Sponsor
Institute	Yokohama University of Pharmacy
Institute
Department

Funding Source
Organization	None
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	2017 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 13 Day
Anticipated trial start date	2017 Year 01 Month 26 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	Partially published
URL releasing results
Results
Other related information	Preparing to submit a paper

Management information
Registered date	2017 Year 01 Month 25 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029718