UMIN-CTR Clinical Trial

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

Infertility

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Suwa Maternity Clinic, Hospital for Obstetrics, Gynecology, and Pediatrics, Japan

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

Co-sponsor

Graduate School of Human and Environmental Studies, Kyoto University, Japan

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

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

Date of disclosure of the study information

2014

Year

10

Month

16

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2014

Year

10

Month

16

Day

Last modified on

2014

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017958