UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027424 |
|---|---|
| Receipt number | 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 | 2020/04/03 10:53:58 |
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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
| Obstetrics 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
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
akiko-mori@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Division of Women's Health and Midwifery
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | 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 | 05 | Month | 21 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031424
