UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020219
Receipt number 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 12:37:51

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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

Obstetrics 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 or person

Institute

Tokyo Medical University

Institute

Department

Personal name



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

Value
https://center6.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