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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
