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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039218
Receipt No. R000044550
Scientific Title A Non-Randomized, Open-Label Retrospective Cohort Study to Examine the Efficacy of 3D Power Doppler and VOCAL Test in Hormone Replacement Cycle Frozen-Thawed Embryo Transfer
Date of disclosure of the study information 2020/01/21
Last modified on 2020/10/26

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Basic information
Public title A Non-Randomized, Open-Label Retrospective Cohort Study to Examine the Efficacy of 3D Power Doppler and VOCAL Test in Hormone Replacement Cycle Frozen-Thawed Embryo Transfer
Acronym A Non-Randomized, Open-Label Retrospective Cohort Study to Examine the Efficacy of 3D Power Doppler and VOCAL Test in Hormone Replacement Cycle Frozen-Thawed Embryo Transfer
Scientific Title A Non-Randomized, Open-Label Retrospective Cohort Study to Examine the Efficacy of 3D Power Doppler and VOCAL Test in Hormone Replacement Cycle Frozen-Thawed Embryo Transfer
Scientific Title:Acronym A Non-Randomized, Open-Label Retrospective Cohort Study to Examine the Efficacy of 3D Power Doppler and VOCAL Test in Hormone Replacement Cycle Frozen-Thawed Embryo Transfer
Region
Japan

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

Objectives
Narrative objectives1 To determine whether endometrial 3D power Doppler and VOCAL results are associated with fertility outcomes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endometrial 3D power Doppler and VOCAL results on the date of the decision of embryo transfer (around day 14 of menstruation)
Key secondary outcomes Pregnancy, delivery, mode of delivery, birth weight, Apgar score, perinatal complications, neonatal complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Endometrial 3D US-PDA assessed by VOCAL software (Plane C and 15-degree rotation step)
Interventions/Control_2 Transvaginal ultrasound for endometrial thickness
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
35 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria *infertile patients undergoing a frozen-thawed embryo transfer (hormonal replacement) cycle at our institution
*both husband and wife are nonsmokers
Key exclusion criteria *male infertility
*uterine malformation
*Uterine fibroids and adenomyosis with luminal deformities
*history of cesarean section
*chocolate cysts > 3 cm in diameter
*marital chromosomal abnormality
*More than two miscarriage
*antiphospholipid antibody syndrome
Target sample size 180

Research contact person
Name of lead principal investigator
1st name Shinnosuke
Middle name
Last name Komiya
Organization HORAC Grand Front Osaka Clinic
Division name Gynecology
Zip code 530-0011
Address 15th Floor Tower B Grand Front Osaka 3-1 Ofuka-cho Kita-ku Osaka JAPAN
TEL +81-(0)6-6377-8824
Email komiya520@ivfjapan.com

Public contact
Name of contact person
1st name Shinnosuke
Middle name
Last name Komiya
Organization HORAC Grand Front Osaka Clinic
Division name Gynecology
Zip code 530-0011
Address 15th Floor Tower B Grand Front Osaka 3-1 Ofuka-cho Kita-ku Osaka JAPAN
TEL +81-(0)6-6377-8824
Homepage URL
Email komiya520@ivfjapan.com

Sponsor
Institute HORAC Grand Front Osaka Clinic
Institute
Department

Funding Source
Organization self-funding
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 Sunkaky Medical Corporation IRB
Address 1-1-14 Nagata-higashi Higashi-osaka Osaka JAPAN
Tel +81-(0)6-4308-8824
Email hirota@ivfosaka.com

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
2020 Year 01 Month 21 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 160
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
2018 Year 12 Month 15 Day
Date of IRB
2018 Year 12 Month 25 Day
Anticipated trial start date
2020 Year 01 Month 25 Day
Last follow-up date
2021 Year 01 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 21 Day
Last modified on
2020 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044550

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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