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Recruitment status Completed
Unique ID issued by UMIN UMIN000014800
Receipt No. 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

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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
Obsterics 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 (%)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Sugiyama Clinic, Division of Reproductive Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017212


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