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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027424
Receipt No. R000031424
Scientific Title Impact of guidance and consultation management program on women undergoing non-ART infertility treatment
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/08

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Basic information
Public title Impact of guidance and consultation management program on women undergoing non-ART infertility treatment
Acronym Guidance and consultation management program on non-ART infertility treatment
Scientific Title Impact of guidance and consultation management program on women undergoing non-ART infertility treatment
Scientific Title:Acronym Guidance and consultation management program on non-ART infertility treatment
Region
Japan

Condition
Condition Women with infertility to receive non-ART infertility treatment
Classification by specialty
Obsterics and gynecology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the impact of the mutual guidance and consultation management program by the reproductive medicine team for women undergoing non-ART infertility treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Health Related Quality of Life
Time of the measurement is at start of treatment, three months later, six months later and 12 months later
Key secondary outcomes 1.Fertility quality of life.
2.The required time until pregnancy: The days from start of treatment to pregnancy test positive; The number of the treatment cycle.
3.The cost of treatment
4.Drop-out rate from treatment: The patients not visiting a hospital for treatment in reason of patients oneself or reason unknown though they are under treatment.
5.Improvement of the lifestyle and physical function: Decrease of smoking behavior, Decrease of excessive intake of alcohol, Appropriate range of BMI, Improvement of menstrual cycle.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention period is six months
Three times interventions at the first time, after three months, and after six months
We perform the guidance and consultation management program by physician and nurse for 30 minites.
No treatment, usual practice to Intervention 1
Interventions/Control_2 Usual practice
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
42 years-old >
Gender Female
Key inclusion criteria 1.The women who receive infertility treatment for the first time, and then she is within two years from starting to try pregnancy, and she is under 42 years old at the entry
2.The women who applies non-ART infertility treatment(timing therapy, ovulation induction, artificial insemination)
3.The women who have unknown infertility, or ovulation failure, or polycystic ovary syndrome, or her partner has mild male infertility
4.The women who have complications that will effect slightly on infertility treatment and pregnancy only for follow-up not to need treatment, or who have a history of previous surgery
5.The women who have not experience of both delivery and childrearing
6.The person who can read and write and talk in Japanese
Key exclusion criteria 1.The women who need in vitro fertilization or micro insemination medically.
2.The women who have already a history of infertility treatment in another hospital.
3.The women who have complications* that need treatment before infertility treatment start or at the same time. *Endometriosis, Uterine myoma, Ovarian cyst, Impaired glucose tolerance, Mental nervous system disease, Cervical zone cytodiagnosis abnormality, Premature ovarian insufficiency
4.The women who have a history of stillbirth or early neonatal death.
Target sample size 310

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Mori
Organization St. Luke's International University
Division name Division of Women's Health and Midwifery
Zip code
Address 10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044 Japan
TEL +81-3-3543-6391
Email akiko-mori@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Mori
Organization St. Luke's International University
Division name Division of Women's Health and Midwifery
Zip code
Address 10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044 Japan
TEL +81-3-3543-6391
Homepage URL
Email akiko-mori@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Division of Women's Health and Midwifery
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 YES
Study ID_1 17-A006
Org. issuing International ID_1 St. Luke's International University
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 07 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 05 Month 21 Day
Last modified on
2017 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031424

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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