Prospective, randomized, controlled study on the performance of the Swemed Sense single lumen aspiration needle with respect to bleeding, performed in Japan, 2013.
Not Applicable
Recruiting
- Conditions
- Infertility
- Registration Number
- JPRN-UMIN000010915
- Lead Sponsor
- Kiba Park Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 350
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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