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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015445
Receipt No. R000017958
Scientific Title Clinical study about effects of exposure to mild hyperbaric oxygen on intractable infertility
Date of disclosure of the study information 2014/10/16
Last modified on 2014/10/16

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Basic information
Public title Clinical study about effects of exposure to mild hyperbaric oxygen on intractable infertility
Acronym Effects of exposure to mild hyperbaric oxygen on infertility
Scientific Title Clinical study about effects of exposure to mild hyperbaric oxygen on intractable infertility
Scientific Title:Acronym Effects of exposure to mild hyperbaric oxygen on infertility
Region
Japan

Condition
Condition Infertility
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of exposure to mild hyperbaric oxygen at 1.25 atmospheres absolute with 36% oxygen on intractable fertility
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes rates of clinical pregnancy
successful birth
Key secondary outcomes treatment period
number of oocyte pick-up
egg collection
fertilization rate
division rate
number of embryo transfer

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Thirty-seven women with intractable infertility, who underwent in vitro fertilization more than 5 times without success. Patients were exposed to mild hyperbaric oxygen at 1.25 atmospheres absolute with 36% oxygen before in vitro fertilization and embryo transfer.
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Women with intractable infertility, who have undergone in vitro fertilization more than 5 times without success, participated in this study with their intention. All participants received an explanation as to the aims of the study and methods of data collection and signed an informed consent form for participation in this study.
Key exclusion criteria None
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. Fumihiko Yoshikawa, M.D., Ph.D.
Organization Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology, and Pediatrics, Japan
Division name Reproduction Center
Zip code
Address Shimosuwa-cho, Suwa-gun, Nagano 393-0077, Japan
TEL 0266-28-6100
Email yoshikawa@smc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dr. Tsuyoshi Shimizu, M.D., Ph.D.
Organization Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology, and Pediatrics, Japan
Division name Shimizu Institute of Space Physiology, Suwa Maternity Clinic
Zip code
Address Shimosuwa-cho, Suwa-gun, Nagano 393-0077, Japan
TEL 0266-28-6100
Homepage URL
Email tsuyoshi@smc.or.jp

Sponsor
Institute Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology, and Pediatrics, Japan
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor Graduate School of Human and Environmental Studies, Kyoto University, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 諏訪マタニティークリニック
(Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology, and Pediatrics, Japan)

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results The rates of clinical pregnancy were 4.9% and 13.8% before and after exposure to mild hyperbaric oxygen, respectively. Thirteen women achieved clinical pregnancy. Five and 2 women gave birth after in vitro fertilization and natural conception, respectively; 1 woman had an extrauterine pregnancy, and 5 women miscarried.
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 Main results already published
Date of protocol fixation
2011 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2013 Year 08 Month 30 Day
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2016 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 16 Day
Last modified on
2014 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017958

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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