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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010915
Receipt No. R000012774
Scientific Title Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.
Date of disclosure of the study information 2013/07/01
Last modified on 2013/06/10

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Basic information
Public title Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.
Acronym Study on the performance of the Swemed Sense single lumen aspiration needle.
Scientific Title Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.
Scientific Title:Acronym Study on the performance of the Swemed Sense single lumen aspiration needle.
Region
Japan

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

Objectives
Narrative objectives1 Transvaginal ultrasound-guided oocyte retrieval for assisted reproduction was first described in 1985. Because of its simplicity and effectiveness, it has gained widespread popularity. Nevertheless, despite the advantages, the aspiration needle may injure the adjacent pelvic organs leading to complications. Other reported complications are bleeding and pelvic infections.
Vitrolife markets a reduced needle, the Swemed Sense single lumen aspiration needle. The first five centimetres of the needle is reduced into a thin tip with a diameter of 20 gauge (G) while the rest of the needle has a standard diameter of 17G. The Swemed Sense™ needle has been evaluated in a prospective study comparing the pain experience among patients undergoing oocyte aspiration by use of either the Swemed Sense needle or a standard needle. Results showed significantly less overall pain in patients among which the Swemed Sense needle was used.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary endpoint for the study is vaginal bleeding, estimated subjectively by the gynaecologist as 'No visible bleeding' or 'Visible bleeding'. Visible bleeding will be further recorded by the gynaecologist then estimated the need of any intervention according to the subgroups in the list below. Some patients may be included in several subgroups.
1. No visible bleeding (no need for treatment)
2. Visible bleeding (with treatment according to subgroups below)
i. Wiping
ii. Foreceps
iii. Laser or suturing
Key secondary outcomes 1. Aspiration time
2. Oocyte recovery rate
3. Oocyte damage grading
4. Utilization rate
5, Fertilization rate
6, Biochemical pregnancy rate
7. implantation rate
8. 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 A: Swemed Sense (20G) with 120 mmHg aspiration pressure
Interventions/Control_2 B: Kitazato needle (18G) with 175 mmHg aspiration pressure
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 Patients undergoing oocyte aspiration 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
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsumi Yoshida
Organization Kiba Park Clinic
Division name Physician
Zip code
Address Kamei Building 2nd Floor, 2-17-13, Kiba, Koto, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Kobayashi
Organization Kiba Park Clinic
Division name Research Division
Zip code
Address
TEL
Homepage URL
Email mamoru.kobayashi@me.com

Sponsor
Institute Kiba Park Clinic
Institute
Department

Funding Source
Organization Kiba Park 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
2013 Year 07 Month 01 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 10 Day
Last modified on
2013 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012774

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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