UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014800
Receipt number R000017212
Scientific Title Prospective, randomized, controlled study to evaluate safety and effectiveness of a newly designed needle with a thin tip on the oocyte retrieval
Date of disclosure of the study information 2014/08/09
Last modified on 2014/08/08 22:09:12

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Basic information

Public title

Prospective, randomized, controlled study to evaluate safety and effectiveness of a newly designed needle with a thin tip on the oocyte retrieval

Acronym

Study to evaluate safety and effectiveness of a newly designed needle with a thin tip on the oocyte retrieval

Scientific Title

Prospective, randomized, controlled study to evaluate safety and effectiveness of a newly designed needle with a thin tip on the oocyte retrieval

Scientific Title:Acronym

Study to evaluate safety and effectiveness of a newly designed needle with a thin tip on the oocyte retrieval

Region

Japan


Condition

Condition

Infertility

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In ART treatment, transvaginal ultrasound-guided oocyte retrieval is basic procedure. However, an aspiration needle may cause massive bleeding during oocyte retreival. Currently a newly designed needle with a thin tip has been launched for oocyte retrieval. This is a reduced needle with lure connection with a 17 gauge body but a 20 gauge tip. The purpose of this study is to evaluate safety and effectiveness of this reduced needle in a prospective study comparing to a standard needle.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The primary endpoints are the rating of pain using Visual Analogue Scale ranging 0 to 10 points and frequency of bleeding. The condition that bleeding did not cease after making direct compression for 30 seconds was defined as bleeding.

Key secondary outcomes

1. Operation time (second)
2. Oocyte recovery rate (%)
3. Fertilization rate (%)
4. Morphological good embryo rate (%)
5. Clinical pregnancy rate (%)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Needle A: a reduced needle with lure connection with a 17 gauge body but a 20 gauge tip

Interventions/Control_2

Needle B:a standard 19 gauge needle

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

20 years-old <

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

Patients undergoing oocyte retrieval for IVF treatment at the clinic

Key exclusion criteria

Patients are not eligible for inclusion in the study if they have:
1. Previously participated in the study
2. A body mass index (BMI) >35
3. Known endometriosis
4. Other contraindications for oocyte aspiration
5. Two or more of developed follicle number

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Nakagawa

Organization

Sugiyama Clinic

Division name

Division of Reproductive Medicine

Zip code


Address

1-53-1, Ohara, Setagaya, Tokyo, Japan

TEL

03-5454-8181

Email

nakagawa-jiko@spice.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Nakagawa

Organization

Sugiyama Clinic

Division name

Division of Reproductive Medicine

Zip code


Address

1-53-1, Ohara, Setagaya, Tokyo, Japan

TEL

03-5454-8181

Homepage URL


Email

nakagawa-jiko@spice.ocn.ne.jp


Sponsor or person

Institute

Sugiyama Clinic, Division of Reproductive Medicine

Institute

Department

Personal name



Funding Source

Organization

Sugiyama Clinic

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 09 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


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

2013 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date

2013 Year 11 Month 30 Day

Date of closure to data entry

2013 Year 11 Month 30 Day

Date trial data considered complete

2013 Year 11 Month 30 Day

Date analysis concluded

2014 Year 08 Month 15 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 08 Day

Last modified on

2014 Year 08 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name