UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044498 |
|---|---|
| Receipt number | R000050787 |
| Scientific Title | Effects of exposure to mild hyperbaric oxygen environment on physiological factors in healthy adult women and infertility women |
| Date of disclosure of the study information | 2021/06/12 |
| Last modified on | 2025/03/31 12:42:15 |
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Basic information
Public title
Studies of the mechanism of improvement in the outcome of infertility treatment with mild hyperbaric oxygen environment (oxygen capsule )
Acronym
Studies of mechanisms of mild hyperbaric oxygen effects
Scientific Title
Effects of exposure to mild hyperbaric oxygen environment on physiological factors in healthy adult women and infertility women
Scientific Title:Acronym
Mechanisms of mild hyperbaric oxygen effects
Region
| Japan |
Condition
Condition
infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have found that mild hyperbaric oxygen improves the outcome of infertility treatment (Fumihiko Yoshikawa et al.: J. Reproductive Medicine. vol.64.339-345.2019 ).It is the main objective of this study to dissolve the mechanism of the improvement.
Basic objectives2
Others
Basic objectives -Others
To measure continuously changes of various parameters in the subject during exposure to mild hyperbaric oxygen environment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative changes of each parameter as a function of time during exposure to the mild hyperbaric oxygen environment /
Changes of oxygen saturation rate
Key secondary outcomes
Difference between two groups (healthy adult women and infertility women) in each parameter : skin blood flow, ECG, pulse wave, heart rate,
RR interval(Frequency ratio analysis),
skin temperature,
blood pressure before/after exposure.
Reference records :
Inside the oxygen room : barometric pressure,
oxygen concentration, room temperature,
humidity.
weather.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Each of twenty healthy adult women and twenty women with infertility is exposed to the environment (oxygen room) at 1.25 atmospheres absolute with 36% oxygen for 90 min. Physiological parameters above described in the Primary and Key secondary outcomes of Assessment in this UMIN Form are continuously recorded in each subject during stay in the room and the electrical sensors(electrodes) are attached at appropriate places on the
skin. The exposure test is performed 3 times (once a week with their intention for the healthy women and before embryo transfer in consultation with the attending physician for the infertility women). A female researcher
stays with the subject in the room.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
Adult women who received an explanation as to the aim and method of this study and wish to join the study with their intention, signing an informed consent form for participation in this study.
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology and Pediatrics
Division name
Shimizu Institute of Space Physiology
Zip code
393-0077
Address
112-13 Yagi, Shimosuwa-machi, Suwa-gun,Nagano-ken
TEL
0266-28-6100
tsuyoshi@smc.or.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Kanai |
Organization
Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology and Pediatrics
Division name
Shimizu Institute of Space Physiology
Zip code
393-0077
Address
112-13 Yagi, Shimosuwa-machi, Suwa-gun, Nagano-ken
TEL
0266-28-6100
Homepage URL
kozo_kanai@smc.or.jp
Sponsor or person
Institute
Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology andPediatrics
Institute
Department
Personal name
Funding Source
Organization
Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology and Pediatrics
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suwa Maternity Crinic, Hospital for Obstetrics, Gynecology and Pediatrics
Address
112-13 Yagi, Shimosuwa-machi
Tel
0266-28-6100
secretary@smc.or.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
| 2021 | Year | 06 | Month | 12 | 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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2021 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050787
