A potential reduction in pain could be obtained by the use of a thinner aspiration needle, 20 Gauge instead of 14 Gauge used right now. This is the reason for setting up a study that looks at the effect on pain perception in women by the use of a…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primarily there will be a look at the difference in pain scores with the use of
a thinner needle.
Secondary outcome
Secondary outcomes were differences in: oocyte quality, total procedure time,
follow procedure/fertilization, demand for additional analgesia during the
procedure, time to resign after puncture, pain medication days after puncture,
possible influence of age and/or weight on pain score, relationship between
pain score and indication puncture, impact doctor performing puncture on pain
score and whether the *overall* savings for the economy, considering
absenteeism, extra medication used, and (next) puncture under general
anaesthesia.
Background summary
Worldwide, 1.5million artificial reproductive technology cycles are performed
each year.
Since the first description in the early 80s, ultrasound-guided follicular
aspiration is the first choice in the ovum pick-up for artificial reproduction
techniques, like IVF and ICSI. While this procedure is safe and effective, it
is described as one of the most stressful and painful components of the entire
process.
Pain is affected in different ways: use of pain medication, duration of the
intervention, practitioner and thickness of the needle. In many countries, the
IVF procedure is done under the presence of an anaesthesiologist. The
anaesthesiologist will sedate the patient with Propofol during the procedure
and the patient is able to go home at the end of the day. In the Netherlands
the majority of the IVF procedure will take place on an outpatient basis
without the presence of the anaesthesiologist and without the use of Propofol,
after which the patient can go home when she feels ready to go. In the context
of pain-reduction, the various factors mentioned above are explored.
Study objective
A potential reduction in pain could be obtained by the use of a thinner
aspiration needle, 20 Gauge instead of 14 Gauge used right now. This is the
reason for setting up a study that looks at the effect on pain perception in
women by the use of a thinner needle and to see if there are related adverse
event.
Study design
A randomised controlled trial in women who will undergo their first IVF or ICSI
treatment. They will be randomized between a transvaginal ultrasound-guided
puncture with the Sense OD 20/17 Gauge needle and a transvaginal
ultrasound-guided puncture with the Origio 14 Gauge needle. They*re asked to
give a VAS-pain score at four different point during the procedure. In
addition, they receive a questionnaire to take home, in which they have to
report the pain scores, the use of pain medication and the effect of the
puncture on their daily lives during the first 4 days after the procedure.
Intervention
A transvaginal ultrasound-guided puncture with the Sense OD 20/17 Gauge needle
or a transvaginal ultrasound-guided puncture with the Origio 14 Gauge needle
for ovum pick up.
Study burden and risks
Nature and extent of the burden and risks for the patients will be the same
with the aspiration needle we use nowadays.
Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Henri Dunantstraat 1
's-Hertogenbosch 5223 GZ
NL
Listed location countries
Age
Inclusion criteria
- Indication for IVF/ICSI
- Female age between 18 and 42 years
- Informed consent
- Normal position of the ovaries
Exclusion criteria
- A previous IVF or ICSI treatment
- Endometriosis
- BMI > 35
- Use of painmedication
- OHSS
- Operation in lower abdomen
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL51390.028.15 |
OMON | NL-OMON22904 |