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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026393
Receipt No. R000030116
Scientific Title Effect of myoinositol on in vitro fertilization/intracytoplasmic sperm injection outcome in infertile patients with polycystic ovarian syndrome: a prospective study.
Date of disclosure of the study information 2017/03/04
Last modified on 2018/03/26

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Basic information
Public title Effect of myoinositol on in vitro fertilization/intracytoplasmic sperm injection outcome in infertile patients with polycystic ovarian syndrome: a prospective study.
Acronym Effect of myoinositol on in vitro fertilization/intracytoplasmic sperm injection outcome in infertile patients with polycystic ovarian syndrome: a prospective study.
Scientific Title Effect of myoinositol on in vitro fertilization/intracytoplasmic sperm injection outcome in infertile patients with polycystic ovarian syndrome: a prospective study.
Scientific Title:Acronym Effect of myoinositol on in vitro fertilization/intracytoplasmic sperm injection outcome in infertile patients with polycystic ovarian syndrome: a prospective study.
Region
Japan

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

Objectives
Narrative objectives1 To clarify if myoinositol supplementation improves in vitro fertilization/intracytoplasmic sperm injection outcome in infertile patients with polycystic ovarian syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oocyte pickup count, mature oocyte count/rate, fertilization rate, blastocyst rate, and live birth rate
Key secondary outcomes Clinical pregnancy rate, implantation rate, and miscarriage rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Oral administration of 4g/day myoinositol plus 400microgram/day folate supplement for 15 days (subject group) 400microgram/day folate supplement for 15 days (control group)

Interventions/Control_2 Oral administration of 400microgram/day folate supplement for 15 days (control group)
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
20 years-old <=
Age-upper limit
39 years-old >=
Gender Female
Key inclusion criteria Infertile patients with polycystic ovarian syndrome undergoing in vitro fertilization/intracytoplasmic sperm injection
Key exclusion criteria Participants with a history of hyper-sensitivity to rice products
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Kitaya
Organization Reproduction Clinic Osaka
Division name IVF Center
Zip code
Address Grand Front Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL 0661363344
Email kitaya@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Kitaya
Organization Reproduction Clinic Osaka
Division name IVF Center
Zip code
Address Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL 0661363344
Homepage URL
Email kitaya@koto.kpu-m.ac.jp

Sponsor
Institute Reproduction Clinic Osaka
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2017 Year 03 Month 04 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 Completed
Date of protocol fixation
2017 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 27 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
2017 Year 03 Month 04 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030116

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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