The primary endpoint of this study is to assess the effect of IVF punction needle thickness on the overall pain experience self-assessed and registered by the patient on a visual analogue scale (VAS 0 = no pain to 10 = worst pain one can imagine)…
ID
Bron
Verkorte titel
Aandoening
IVF punction needle VAS pain
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pain score during IVF punction
Achtergrond van het onderzoek
Women undergoing oocyte retrieval in The Netherlands seem to indicate more pain compared to women undergoing oocyte retrieval in other countries. A possible explanation of this is the use of a relative large diameter aspiration needle in our hospital, 16 Gauge. Therefore, we designed a prospective randomized study to evaluate the effect of a needle with reduced diameter on the pain women experience as well as the possible negative side effects, such as oocyte quality.
Doel van het onderzoek
The primary endpoint of this study is to assess the effect of IVF punction needle thickness on the overall pain experience self-assessed and registered by the patient on a visual analogue scale (VAS 0 = no pain to 10 = worst pain one can imagine) during oocyte retrieval.
Onderzoeksopzet
T0: before starting the punction
T1: Immediately after the oocyte aspiration
- the VAS score at that time
- the VAS score of the maximum pain during the IVF/ICSI procedure
T2: 5 minutes after the punction
T3: 30 minutes after the punction
T4: day after
T5: 4days after
Onderzoeksproduct en/of interventie
16 G versus 20 G IVF needle in IVF ICSI patients
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Indication for IVF or ICSI
- Age of the woman between 18 and 42 years
- Signed the informed consent
- Normally positioned ovaries
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Previous IVF or ICSI procedure
- Severy endometriosis (Grades III-IV, endometrial thickness on ultrasound > 4 cm or laparoscopically confirmed grades III-IV)
- BMI > 35 kg/m2
- Standard use of analgesia
- Hyperstimulation
- History of surgery in the lower abdomen
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5781 |
| NTR-old | NTR6064 |
| CCMO | NL51390.028.15 |
| OMON | NL-OMON47399 |