Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response.
Is a modified double-lumen aspiration needle system with follicular flushing able to increase the mean oocyte yield by at least one in poor response IVF patients as compared to single-lumen needle aspiration without flushing?



Follicular flushing with the modified flushing system did not increase the number of oocytes, but increased the procedure duration.



Most studies on follicular flushing were performed with conventional double-lumen needles in patients who were normal responders. Overall, these studies indicated no benefit of follicular flushing.



Prospective, single-centre, randomized, controlled, open, superiority trial comparing the 17 G Steiner-Tan Needle® flushing system with a standard 17 G single-lumen aspiration needle (Gynetics®); time frame February 2015-March 2016.



Eighty IVF patients, 18-45 years, BMI >18 kg/m2 to <35 kg/m2, presenting with ≤ five follicles >10 mm in both ovaries at the end of the follicular phase were randomized to either aspirating and flushing each follicle 3× with the Steiner-Tan-Needle® automated flushing system (n = 40) or a conventional single-lumen needle aspiration (n = 40). Primary outcome was the number of cumulus-oocyte-complexes (COCs). Procedure duration, burden (Depression Anxiety and Stress Scale; DASS-21) and post-procedure pain were also assessed.



Flushing was not superior with a mean (SD) number of COCs of 2.4 (2.0) and 3.1 (2.3) in the Steiner-Tan Needle® and in the Gynectics® group, respectively (mean difference -0.7, 95% CI: 0.3 to -1.6; P = 0.27). Likewise no differences were observed in metaphase II  oocytes, two pronuclear oocytes, number of patients having an embryo transfer and DASS 21 scores. The procedure duration was significantly 2-fold increased.



Testing for differences in the number of patients achieving an embryo transfer or differences in pregnancy rate would require a much larger sample size.



The use of follicular flushing is unlikely to benefit the prognosis of patients with poor ovarian response.



The Steiner-Tan Needles® and the flushing system were provided for free by the manufacturer. K.v.H. has received personal fees from Finox and non-financial support from Merck-Serono; M.D. has received personal fees from Finox and non-financial support from Merck-Serono. A.S.-M. has received personal fees and non-financial support from M.D., Ferring, Merck-Serono, Finox, TEVA. G.G. has received personal fees and non-financial support from M.D., Ferring, Merck-Serono, Finox, TEVA, IBSA, Glycotope, as well as personal fees from VitroLife, NMC Healthcare LLC, ReprodWissen LLC and ZIVA LLC.



NCT 02365350 (clinicaltrials.gov).



Sixth of February 2015.



Ninth of February 2015.
Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck,Lübeck, Germany.
Kyra
K
von Horn
Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck,Lübeck, Germany.
Marion
M
Depenbusch
Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck,Lübeck, Germany.
Askan
A
Schultze-Mosgau
Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck,Lübeck, Germany.
Georg
G
Griesinger
D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D006801:Humans; D054315:Oocyte Retrieval / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D010062:Ovulation Induction; D010149:Postoperative Pain; D019152:Paracentesis / Q000295:instrumentation*; D011247:Pregnancy; D018873:Pregnancy Rate; D013997:Time Factors; D016896:Treatment Outcome
IVF; IVF outcome; double-lumen needle; flushing; ovarian response; poor response