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

Abstract

Ninth of February 2015.

Outcomes of Follicular Flushing Versus Nonflushing Aspiration in Poor Ovarian Responders Women Undergoing Intracytoplasmic Sper Injection - Embryo Transfer: A Randomized Clinical Trial.

“…This trial was the 4 th trial comparing FFA and NFA of OPU in women with POR in ART-ET cycles. The present study was in agreement with either RCT s (10,11,12) , and SR&Ms (8,9) regards that FFA versus NFA prolong the procedure as well as the anesthesia time without any gaining values in the number of retrieved COCs as well as MII oocytes. Also the outcomes of the present trial were in agreement with results of the two RCTs (11,12) and the two SR &Ms (8,9) regards that the FFA didn't induce a detrimental impacts on retrieved oocytes with consequently lower fertilization rate (66.7 FFA vs 81.7 NFA) and a statistically significant lower total embryo cleavage (1.9  0.7 in FFA vs 2.8  1.2 in NFA, p = 0.01), lower embryo grade (2  0.4 vs 2.2  0.6, p = 0.03), lower implantation rate (5.3% vs 34.2%, p = 0.006), lower clinical pregnancy rate per cycle (4% vs 36%, p = 0.01) and lower live birth rate per cycle (4% vs 20%, p = 0.19) as reported in Mok-Lin et al trial (10) .…”

“…The present study was in agreement with either RCT s (10,11,12) , and SR&Ms (8,9) regards that FFA versus NFA prolong the procedure as well as the anesthesia time without any gaining values in the number of retrieved COCs as well as MII oocytes. Also the outcomes of the present trial were in agreement with results of the two RCTs (11,12) and the two SR &Ms (8,9) regards that the FFA didn't induce a detrimental impacts on retrieved oocytes with consequently lower fertilization rate (66.7 FFA vs 81.7 NFA) and a statistically significant lower total embryo cleavage (1.9  0.7 in FFA vs 2.8  1.2 in NFA, p = 0.01), lower embryo grade (2  0.4 vs 2.2  0.6, p = 0.03), lower implantation rate (5.3% vs 34.2%, p = 0.006), lower clinical pregnancy rate per cycle (4% vs 36%, p = 0.01) and lower live birth rate per cycle (4% vs 20%, p = 0.19) as reported in Mok-Lin et al trial (10) . The presented trial was on the contrary to Mok-Lin et al (10) trial regards the proposed detrimental mechanisms associated with flushing follicular aspiration of OPU including introduction of culture media, impacts of high flushing pressure as well as proposed increased retrieval of immature oocytes and alteration of COCs granulosa cell numbers and function with its consequences on the outcomes of ICSI as well as outcomes of ART-ET cycles (10) .…”

“…So, it is recommended to conduct a larger sample size trial or multicenter one taking into consideration live birth rate as a prior determining factor of sample size. This RCT likes others 2 RCTs (11,12) and 2 SR &Ms (8,9) found neither beneficial nor detrimental impacts of three times follicular flushing ovum pick up via modified single lumen needle over conventional single lumen needle direct non-flushing follicular ovum pick up regards any outcomes from the number of retrieved oocytes to live birth rate.…”

“…However, this physician did not include any more in any other part of the trial, and this could not be avoided owing to the nature of procedures. Inadequate power of this trial likes others prior RCTs (10,11,12) taking in consideration impacts of OPU techniques in women with POR in ART-ET cycles regards evaluation of more important outcomes of the ART-ET cycles namely ongoing pregnancy rate as well as live birth rate, however such items required 200 -400 POR patients per group which was behind the capacity of most IVF center and required a long period of time as well as considering participating of multiple IVF centers, however accumulation of patients with POR from different RCTs (10,11,12,13) could resolve such problem. Another limitation of the presented study is the exclusion of natural cycles and women with mono-follicular growth.…”

“…Strengths in the present study include its prospective nature, randomization, blinding of included embryologist, embryo transferring physician as well as Participating patients and follow up physician. Taking a step further in 98 RCTs assessing impacts of FFA versus NFA techniques on OPU outcomes through adequate power choosing total cleavage embryo as determining item in assessing the prior sample size compared to previously published RCTs (10,11,12,13) whom determining their sample sizes on the differences in the number of retrieved COCs. Storage of treatment allocation schedule by the chief nurse at the Hawa IVF center by utilizing closed sealed enveloped techniques insured concealment of the allocation procedures.…”