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van CCT (UK)

van CCT (UK)

PAIN study

- candidate number25207
- NTR NumberNTR6064
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2016
- Secondary IDsNL51390.028.15 
- Public TitlePAIN study
- Scientific TitlePain Assessment of the IVF Needle.
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedIVF, Injection, Pain
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2018
- Target number of participants74
- Interventions16 G versus 20 G IVF needle in IVF ICSI patients
- Primary outcomePain relieve during IVF punction
- Secondary outcomeSecondary 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 NRS score
- does body weight (Body Mass Index (BMI))affect the NRS score
- is there a relation between NRS score and indication of the procedure
- does the IVF doctor affect the NRS score
- are there overall socio-economical advantages, such as: absence through illness, the use of extra medication/analgesia and oocyte retrievals under general anesthesia
- TimepointsT0: before starting the punction
T1: Immediately after the oocyte aspiration
- the NRS score at that time
- the NRS 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
- Trial web site-
- statusplanned
- Sponsor/Initiator Jeroen Bosch Hospital
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summaryWomen 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.
- Main changes (audit trail)
- RECORD29-aug-2016 - 3-nov-2016

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