UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046552 |
|---|---|
| Receipt number | R000053111 |
| Scientific Title | Effectiveness of an online program to support partnerships in preventing deterioration of quality of life for men undergoing infertility treatment: Non-randomized parallel group study |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2023/07/09 13:43:21 |
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Basic information
Public title
Effectiveness of an online program to support partnerships in preventing deterioration of quality of life for men undergoing infertility treatment.
Acronym
Effectiveness of an online program to support partnerships in preventing deterioration of quality of life for men undergoing infertility treatment.
Scientific Title
Effectiveness of an online program to support partnerships in preventing deterioration of quality of life for men undergoing infertility treatment: Non-randomized parallel group study
Scientific Title:Acronym
Effectiveness of an online program to support partnerships in preventing deterioration of quality of life for men undergoing infertility treatment.
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the effectiveness of an online program of partnership support for men undergoing infertility treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of Life: QOL
Key secondary outcomes
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
| Other |
Interventions/Control_1
Online program for partnership support
Interventions/Control_2
usual care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Couples undergoing infertility treatment (survey is conducted for men).
(2) Undergoing examination or treatment for at least one month after the start of the examination.
Key exclusion criteria
a person with sexual dysfunction.
Target sample size
246
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Asazawa |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
0357795031
k-asazawa@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Asazawa |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro-ku, Tokyo
TEL
0357795031
Homepage URL
k-asazawa@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Tokyo Healthcare University
Address
4-1-17 higashigotanda, Shinagawa-ku, Tokyo
Tel
03-5421-7685
kenkyo@thcu.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
| 2022 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jjns.12536
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jjns.12536
Number of participants that the trial has enrolled
151
Results
There were no significant interaction effects between program and time in the FertiQoL and Distress scales. However, there were significant interaction effects between program and time in the Relational (p < .001) and Social (p = .044) subscales. Subgroup analysis showed that in the non-assisted reproductive technologies group, deterioration in the quality of life was more effectively prevented in the intervention group than in the control group.
Results date posted
| 2023 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The present study was conducted among 151 infertile couples in Japan from January to April of 2022 at a leading fertility clinic in Tokyo, Japan. Potential participants were couples referred to the clinic for infertility treatment. The inclusion criteria were as follows: 1.being within 3 years of the infertility treatment, 2.knowing the causes of infertility, including unexplained causes, 3.male patients undergoing infertility treatment and currently undergoing treatment as a male infertility outpatient (both types with and without a male factor), and 4.participation in a program as a couple. The exclusion criterion was the presence of any sexual dysfunctions.
Participant flow
There were 82 patients in the intervention group and 81 patients in the control group who met the inclusion criteria. There were 75 patients in the intervention group and 76 patients in the control group who agreed to participate. There were 31 (20.4%) dropouts because of lack of data or failure to return the questionnaire. The final analysis included 58 participants in the intervention group and 62 participants in the control group.
Adverse events
None
Outcome measures
QOL
Distress
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053111
