UMIN-CTR Clinical Trial

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