***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: The sperm – hyaluronan binding assay ( HBA ) is a diagnostic kit for assessing sperm maturity , function and fertility . The aim of this prospect i ve cohort pilot study was to evaluate the relationship between HBA and WHO sperm parameters ( motility , concentration and detailed morphology ) and possible influence of sperm processing on hyaluronic acid binding . A cohort of 68 patients undergoing a first combo in vitro fertilisation/intracytoplasmic sperm injection treatment after failure of three or more intrauterine insemination cycles were included in the study . Outcome measures studied were fertilisation rate , embryo quality , ongoing pregnancy rate and cumulative pregnancy rate .  HBA outcome improved after sperm preparation and culture , but was not correlated to detailed sperm morphology , concentration or motility .  HBA did not provide additional information for identifying patients with poor or absent fertilisation , although the latter had more immature sperm cells and cells with cytoplasmic retention present in their semen . HBA outcome in the neat sample was significantly correlated with embryo quality , with miscarriage rates and ongoing pregnancy rates in the fresh cycles , but not with the cumulative ongoing pregnancy rate . No threshold value for HBA and outcome in combo IVF/ICSI treatment could be established . The clinical value for HBA in addition to routine semen analysis for this patient population seems limited The purpose of this study was to investigate whether sperm selection by hyaluronic acid ( HA ) binding could improve fertilization rate and embryo quality in intracytoplasmic sperm injection ( ICSI ) cycles . Two hundred nineteen oocytes obtained from eighteen women were injected with either HA-bound ( n = 107 ) or conventionally selected spermatozoa ( n = 112 ) in a r and omized way . All of the participants were infertile couples who had normal sperm parameters but low fertilization rate in previous in vitro fertilization ( IVF ) cycle ( n = 5 ) or experienced multiple IVF failures ( n = 13 ) .  Lower fertilization ( 75.7 % vs 83.0 % ) and cleavage rate on day 2 ( 72.9 % vs 83.0 % ) was observed in oocytes injected with HA-bound spermatozoa than the conventional group , but the difference was not significant . Significantly lower cleavage rate was observed on day 3 in HA group ( 56.0 % vs 69.6 % , P = 0.038 ) . Blastocyst formation rate and the number of transferred embryos were similar in both groups . In multiple IVF failure patients , significantly reduced fertilization rate ( 71.8 % vs 85.3 % , P = 0.046 ) and cleavage rate on day 2 ( 70.4 % vs 85.3 % , P = 0.029 ) and day 3 ( 53.5 % vs 77.3 % , P = 0.002 ) were noticed in HA group . Five women achieved pregnancy continuing more than 12 weeks after transfer ( 27.8 % ) . Success of ICSI was not related with the number of embryos fertilized by HA-bound spermatozoa . Application of ICSI by sperm selection using HA binding is not helpful in couples with repeated poor fertilization or implantation despite normal sperm parameters STUDY QUESTION Does the selection of sperm for ICSI based on their ability to bind to hyaluronan  improve the clinical pregnancy rates ( CPR ) ( primary end-point ) , implantation ( IR ) and pregnancy loss rates ( PLR ) ? SUMMARY ANSWER In couples where ≤65 % of sperm bound hyaluronan , the selection of hyaluronan-bound ( HB ) sperm for ICSI led to a statistically significant reduction in PLR . WHAT IS KNOWN AND WHAT THIS PAPER ADDS HB sperm demonstrate enhanced developmental parameters which have been associated with successful fertilization and embryogenesis . Sperm selected for ICSI using a liquid source of hyaluronan achieved an improvement in IR . A pilot study by the primary author demonstrated that the use of HB sperm in ICSI was associated with improved CPR . The current study represents the single largest prospect i ve , multicenter , double-blinded and r and omized controlled trial to evaluate the use of hyaluronan in the selection of sperm for ICSI . DESIGN Using the hyaluronan binding assay , an HB score was determined for the fresh or initial ( I-HB ) and processed or final semen specimen ( F-HB ) . Patients were classified as > 65 % or ≤65 % I-HB and stratified accordingly . Patients with I-HB scores ≤65 % were r and omized into control and HB selection ( HYAL ) groups whereas patients with I-HB > 65 % were r and omized to non-participatory ( NP ) , control or HYAL groups , in a ratio of 2:1:1 . The NP group was included in the > 65 % study arm to balance the higher prevalence of patients with I-HB scores > 65 % . In the control group , oocytes received sperm selected via the conventional assessment of motility and morphology . In the HYAL group , HB sperm meeting the same visual criteria were selected for injection . Patient participants and clinical care providers were blinded to group assignment . PARTICIPANTS AND SETTING Eight hundred two couples treated with ICSI in 10 private and hospital-based IVF programs were enrolled in this study . Of the 484 patients stratified to the I-HB > 65 % arm , 115 participants were r and omized to the control group , 122 participants were r and omized to the HYAL group and 247 participants were r and omized to the NP group . Of the 318 patients stratified to the I-HB ≤ 65 % arm , 164 participants were r and omized to the control group and 154 participants were r and omized to the HYAL group . MAIN RESULTS AND THE ROLE OF CHANCE HYAL patients with an F-HB score ≤65 % demonstrated an IR of 37.4 % compared with 30.7 % for control [ n = 63 , 58 , P > 0.05 , ( 95 % CI of the difference −7.7 to 21.3 ) ] . In addition , the CPR associated with patients r and omized to the HYAL group was 50.8 % when compared with 37.9 % for those r and omized to the control group ( n = 63 , 58 , P > 0.05 ) . The 12.9 % difference was associated with a risk ratio ( RR ) of 1.340 ( RR 95 % CI 0.89–2.0 ) . HYAL patients with I-HB and F-HB scores ≤65 % revealed a statistically significant reduction in their PLR ( I-HB : 3.3 versus 15.1 % , n = 73 , 60 , P = 0.021 , RR of 0.22 ( RR 95 % CI 0.05–0.96 ) ( F-HB : 0.0 % , 18.5 % , n = 27 , 32 , P = 0.016 , RR not applicable due to 0.0 % value ) over control patients . The study was originally planned to have 200 participants per arm providing 86.1 % power to detect an increase in CPR from 35 to 50 % at α = 0.05 but was stopped early for financial reasons . As a pilot study had demonstrated that sperm preparation protocol s may increase the HB score , the design of the current study incorporated a priori collection and analysis of the data by both the I-HB and the F-HB scores . Analysis by both the I-HB and F-HB score acknowledged the potential impact of sperm preparation protocol s. BIAS , CONFOUNDING AND OTHER REASONS FOR CAUTION Selection bias was controlled by r and omization . Geographic and seasonal bias was controlled by recruiting from 10 geographically unique sites and by sampling over a 2-year period . The potential for population effect was controlled by adjusting for higher prevalence rates of > 65 % I-HB that naturally occur by adding the NP arm and to concurrently recruit > 65 % and ≤65 % I-HB subjects . Monitoring and site audits occurred regularly to ensure st and ardization of data collection , adherence to the study protocol and subject recruitment . Subgroup analysis based on the F-HB score was envisaged in the study design . GENERALIZABILITY TO OTHER POPULATION S The study included clinics using different sperm preparation methods , located in different regions of the USA and proceeded in every month of the year . Therefore , the results are widely applicable . STUDY FUNDING /COMPETING INTEREST(S ) This study was funded by Biocoat , Inc. , Horsham , PA , USA . The statistical analysis plan and subsequent analyses were performed by Sherrine Eid , a biostatistician . The manuscript was prepared by Kathryn C. Worrilow , Ph.D. and the study team members . Biocoat , Inc. was permitted to review the manuscript and suggest changes , but the final decision on content was exclusively retained by the authors . K.C.W is a scientific advisor to Biocoat , Inc. S.E. is a consultant to Biocoat , Inc. D.W. has nothing to disclose . M.P. , S.S. , J.W. , K.I. , C.K. and T.E. have nothing to disclose . G.D.B. is a consultant to Cooper Surgical and Unisense . J.L. is on the scientific advisory board of Origio . TRIAL REGISTRATION NUMBER NCT00741494 Purpose Hyaluronic Acid ( HA ) has a role as “ physiologic selector ” for spermatozoa prior to intracytoplasmic sperm injection ( ICSI ) . The objective of this study is to analyze the results achievable by the introduction of a routine HA-ICSI programme . Methods We retrospectively observed 293 couples treated with HA-ICSI versus 86 couples treated with conventional PVP-ICSI ( historical control group ) . ICSI was performed on a limited number of oocytes per patient ( 1–3 ) according to Italian IVF law at the time of the study . Main outcome measures observed were : fertilization , embryo quality , implantation and pregnancy . Results This study showed that Injection of HA-bound spermatozoa ( HA-ICSI ) significantly improves embryo quality and implantation . Conclusions If wider multi-center r and omized studies will confirm these beneficial effects on ICSI outcome , HA could be considered as a routine choice for “ physiologic ” sperm selection prior to ICSI BACKGROUND There is a growing awareness of potential problems in exposing sperm to polyvinylpyrrolidone ( PVP ) to slow their motility , a procedure commonly used prior to ICSI . The study presented here evaluates an alternative product for slowing sperm motility , which contains hyaluronate , a substance found naturally in the reproductive tract . METHODS Computerized sperm motility analysis was used to compare the motilities of sperm exposed to either a PVP-containing product ( ICSI-100 ) , or a hyaluronate-containing product ( SpermCatch ) , or control sperm resuspended in a sperm maintenance medium .  A subjective assessment was made of the ease with which sperm could be isolated and be drawn into , and expelled from , an injection pipette after having their tails nicked . Sperm exposed to either ICSI-100 or SpermCatch were used for ICSI . Fertilization rate , zygote development , grading , and outcome of transfer were recorded for the two treatment groups . RESULTS The hyaluronate-containing product slowed sperm motility sufficiently for the sperm to be captured in an injection pipette , was easy to draw into and expel from the pipette , prevented sperm sticking to plastic or glassware , and did not affect post-injection zygote development . Clinical pregnancy rates were similar for the two groups . CONCLUSIONS This product represents an alternative to PVP for slowing sperm motility prior to ICSI OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological 
    Output:
    
Evidence does not support routine use of hyaluronic acid binding assays in all ICSI cycles .