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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020219
Receipt No. R000023351
Scientific Title To evaluate the outcomes of a novel ET method which double embryos transferred to the separate position on DET (s-DET) compared to those of the conventional DET (c-DET) in Assisted Reproductive Technology (ART) treatment
Date of disclosure of the study information 2015/12/16
Last modified on 2016/12/20

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Basic information
Public title To evaluate the outcomes of a novel ET method which double embryos transferred to the separate position on DET (s-DET) compared to those of the conventional DET (c-DET) in Assisted Reproductive Technology (ART) treatment
Acronym To evaluate the outcomes of a novel ET method which double embryos transferred to the separate position on DET
Scientific Title To evaluate the outcomes of a novel ET method which double embryos transferred to the separate position on DET (s-DET) compared to those of the conventional DET (c-DET) in Assisted Reproductive Technology (ART) treatment
Scientific Title:Acronym To evaluate the outcomes of a novel ET method which double embryos transferred to the separate position on DET
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the outcomes of a novel embryo transfer (ET) method in which double embryos are transferred separately (s-DET) compared with those of conventional DET (c-DET).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reproductive outcomes including human chorionic gonadotropin levels, gestational sac development, and clinical pregnancy, implantation, multiple pregnancy, and miscarriage rates were compared between the s-DET and c-DET groups.
Key secondary outcomes

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Some patients underwent s-DET in which two embryos were transferred separately.
Interventions/Control_2 Other patients underwent c-DET in which two embryos were transferred together.
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 Study patients are selected if they are eligible for in vitro fertilization (IVF)/ET and had a history of two or more failed IVF/ET cycles with morphologically and developmentally average to good quality embryos transferred into an adequately prepared endometrium.
Key exclusion criteria None of the patients have submucosal fibroids, endometrial polyps, intrauterine adhesions, congenital anomalies of the uterus, or hydrosalpinges. In addition, none of the patients have any history of or an active autoimmune disease.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TOMOYA HASEGAWA
Organization Tokyo Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 6-7-1, Nishi-Shinjyuku, Shinjyuku, Tokyo, 160-0023, Japan
TEL 03-3342-6111
Email ppppq999@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name TOMOYA HASEGAWA
Organization Tokyo Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 6-7-1, Nishi-Shinjyuku, Shinjyuku, Tokyo, 160-0023, Japan
TEL 03-3342-6111
Homepage URL
Email ppppq999@gmail.com

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization None
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
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 Sugiyama Clinic

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We found that clinical pregnancy and implantation rates in s-DET group were 25.5% and 13.1%, respectively, which were similar to those in c-DET group (24.2% and 14.9%, respectively). However, multiple pregnancy rate was 2.9% in s-DET group, significantly lower than that in c-DET group (23.5%; P < 0.01). Although s-DET is similar to c-DET, except that double embryos are separately transferred, multiple pregnancy rate in s-DET group was significantly lower than that in c-DET group. Therefore, s-DET may become a novel method to prevent multiple gestations.
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
2015 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
2016 Year 10 Month 10 Day
Date trial data considered complete
2016 Year 10 Month 22 Day
Date analysis concluded
2016 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 16 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023351

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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