Related Experiment Video
Updated: Mar 5, 2026
OP-IVM: Combining In vitro Maturation after Oocyte Retrieval with Gynecological Surgery
Published on: May 9, 2021
Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen
Kyra von Horn1, Marion Depenbusch1, Askan Schultze-Mosgau1
1Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Lübeck,Lübeck, Germany.
Study Question:
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?
Summary Answer:
Follicular flushing with the modified flushing system did not increase the number of oocytes, but increased the procedure duration.
What Is Known Already:
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.
Study Design Size, Duration:
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.
Participants/Materials Setting Methods:
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.
Main Results And The Role Of Chance:
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.
Limitations Reasons For Caution:
Testing for differences in the number of patients achieving an embryo transfer or differences in pregnancy rate would require a much larger sample size.
Wider Implications Of The Findings:
The use of follicular flushing is unlikely to benefit the prognosis of patients with poor ovarian response.
Study Funding/Competing Interest(S):
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.
Trial Registration Number:
NCT 02365350 (clinicaltrials.gov).
Trial Registration Date:
Sixth of February 2015.
Date Of First Patient'S Enrolment:
Ninth of February 2015.
