No registrations found.
ID
Source
Brief title
Health condition
IVF punction needle VAS pain
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain score during IVF punction
Secondary outcome
Secondary end-points are the following:
- the effect of needle diameter on oocyte quality
- the effect of needle diameter on the total time of the procedure of oocyte retrieval
- the effect of needle diameter on fertilization and ongoing pregnancy rate
- the effect of needle diameter on the need of extra intravenous sedation
- the effect of needle diameter on the amount of oral analgesia used the days after the procedure
- does age affect the VAS score
- does body weight (Body Mass Index (BMI))affect the VAS score
- is there a relation between VAS score and indication of the procedure
- does the IVF doctor affect the VAS score
- are there overall socio-economical advantages, such as: absence through illness, the use of extra medication/analgesia and oocyte retrievals under general anesthesia
Background summary
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.
Study objective
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.
Study design
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
Intervention
16 G versus 20 G IVF needle in IVF ICSI patients
Inclusion criteria
- Indication for IVF or ICSI
- Age of the woman between 18 and 42 years
- Signed the informed consent
- Normally positioned ovaries
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5781 |
| NTR-old | NTR6064 |
| CCMO | NL51390.028.15 |
| OMON | NL-OMON47399 |