Human reproduction (Oxford, England) · 2017
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.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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von Horn Kyra, Depenbusch Marion, Schultze-Mosgau Askan, Griesinger Georg
Аннотация
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.
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.