UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026393 |
|---|---|
| Receipt number | 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 | 2022/04/05 12:25:42 |
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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
| Obstetrics 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 | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
5300011
Address
Grand Front Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
kitaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Kitaya |
Organization
Reproduction Clinic Osaka
Division name
IVF Center
Zip code
5300011
Address
Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL
0661363344
Homepage URL
kitaya@koto.kpu-m.ac.jp
Sponsor or person
Institute
Reproduction Clinic Osaka
Institute
Department
Personal name
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
Reproduction Clinic Osaka
Address
Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel
0661363344
kitaya@koto.kpu-m.ac.jp
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
https://doi.org/10.12891/ceog4567.2019
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.12891/ceog4567.2019
Number of participants that the trial has enrolled
50
Results
Myoinositol supplementation on intracytoplasmic sperm injection outcome in Japanese infertile polycystic ovarian syndrome women with non-obese less-androgenic phenotype: a prospective controlled observational study
K. Kitaya, Y. Takaya, R. Nishiyama, K. Yamaguchi, H. Matsubayashi, T. Takeuchi, S. Mizuta1, T. Ishikawa
Clin. Exp. Obstet. Gynecol. 2019, 46(4), 549-552
Results date posted
| 2022 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 11 | Day |
Baseline Characteristics
Infertile polycystic ovarian syndrome women with non-obese less-androgenic phenotype
Participant flow
Non-randomized prospective controlled observational study
Adverse events
None.
Outcome measures
Oocyte retrieval outcome/
Assisted Reproductive Technology Outcome
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030116
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/07 | Text, PCOS Myoinositol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/04/07 | Text, PCOS Myoinositol.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/07 | Table, PCOS Myoinositol.docx |
