A randomized controlled study comparing XXXX experience between a newly designed needle with a thin tip and a standard needle for oocyte aspiration.

@entity1 @entity3556 @entity146 @entity1337 @entity158
BACKGROUND; Ultrasound-guided transvaginal oocyte retrieval is often performed under local anaesthesia on an outpatient basis. The objective of this study was to compare the @entity158 experience of a newly designed @entity146 ( @entity146 ) compared with a thicker standard needle (SN). METHODS: A prospective, randomized, multi-centre study was performed at four different clinics from June to December 2009. The oocyte aspiration was performed under local anaesthesia, either with a needle with a reduced diameter (0.9 mm) for the last 50 mm from the tip ( @entity146 ) or with a SN (1.4 mm). A total of 257 @entity1 were randomized ( @entity146 : n = 129; SN: n = 128). The primary endpoint was the @entity158 experience self-assessed and registered by the @entity1 on a visual analogue scale (VAS 0 mm = no @entity158 to 100 mm = unbearable @entity158 ) immediately after the oocyte retrieval. Secondary end-points such as @entity3556 and several embryological parameters were also registered. RESULTS: The @entity158 during the oocyte retrieval procedure was significantly lower in the @entity146 group than in the SN group (mean 21.0 mm, SD 17.5 mm and median 19.0 mm versus mean 26.0 mm, SD 19.9 mm and median 24.0 mm; P = 0.040, difference between groups mean-5.0 mm, 95% CI: 9.7 to-0.4). This was also true when adjusting for baseline characteristics such as number of follicles, number of previous oocyte pick-up, body mass index and age, by a multiple linear regression analysis. Significantly more @entity1 (40 of 126) had less than expected @entity3556 in the @entity146 group when compared with the SN group (24 of 124; 32 versus 19%; P = 0.03 and 95% CI 1.7-23.0%). No differences were found between the two needles with regard to additional i.v. @entity1337 , aspiration time, oocyte recovery, fertilization, cleavage rate, number of good quality embryos, number of embryos for freezing and pregnancy rate. CONCLUSIONS: Oocyte aspiration performed with the newly designed thinner-tipped needle resulted in significantly less @entity158 and less @entity3556 , without prolonging the retrieval procedure or influence the oocyte recovery rate, when compared with a SN. Clinicaltrials.gov: NCT00924885.
