Unique ID issued by UMIN | UMIN000010915 |
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Receipt number | 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 11:04:07 |
Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.
Study on the performance of the Swemed Sense single lumen aspiration needle.
Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.
Study on the performance of the Swemed Sense single lumen aspiration needle.
Japan |
Infertility
Obstetrics and Gynecology |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
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
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
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Prevention
Device,equipment |
A: Swemed Sense (20G) with 120 mmHg aspiration pressure
B: Kitazato needle (18G) with 175 mmHg aspiration pressure
Not applicable |
Not applicable |
Female
Patients undergoing oocyte aspiration for IVF treatment at the clinic
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
350
1st name | |
Middle name | |
Last name | Atsumi Yoshida |
Kiba Park Clinic
Physician
Kamei Building 2nd Floor, 2-17-13, Kiba, Koto, Tokyo, Japan
1st name | |
Middle name | |
Last name | Mamoru Kobayashi |
Kiba Park Clinic
Research Division
mamoru.kobayashi@me.com
Kiba Park Clinic
Kiba Park Clinic
Other
NO
2013 | Year | 07 | Month | 01 | Day |
Unpublished
Open public recruiting
2013 | Year | 05 | Month | 01 | Day |
2013 | Year | 06 | Month | 15 | Day |
2013 | Year | 06 | Month | 10 | Day |
2013 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012774
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