Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010915

Enrollment

350

Registered

2013-07-01

Start date

2013-06-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Interventions

A: Swemed Sense (20G) with 120 mmHg aspiration pressure B: Kitazato needle (18G) with 175 mmHg aspiration pressure

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients undergoing oocyte aspiration for IVF treatment at the clinic

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMamoru Kobayashi

Kiba Park Clinic Research Division

mamoru.kobayashi@me.com

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026