N/A
N=257
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT00924885 ↗Enrolled (actual)
257
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Visual Analogue Scale — 21.0; 26.0 0-100 mm — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Swemed Follicle Aspiration Set Reduced Single Lumen (Device); Swemed Follicle Aspiration Set Single Lumen (1.4 mm) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Vitrolife
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale |
21.0; 26.0 | 0.04 sig |
| SECONDARY Intervention Because of Bleeding |
40; 24; 80; 93; 6; 7 | — |
Summary
The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the procedure.
Eligibility Criteria
Inclusion Criteria
- The patient has signed an informed consent form before the oocyte retrieval
- The patient is undergoing oocyte retrieval with local anaesthesia
- The patient can speak and understand Swedish
Exclusion Criteria
- The patient has previously participated in Vitrolife-needle-01 study
- The patient has a body mass index ≥35
- Other contra indicator for oocyte retrieval
Data sourced from ClinicalTrials.gov (NCT00924885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.