***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: PURPOSE The purpose of this prospect i ve , r and omized study was to compare ovarian response and oocyte and embryo yields in women undergoing ovulation induction for IVF/ICSI using recombinant human FSH ( rhFSH ) alone or in combination with recombinant human LH ( rhLH ) . METHODS Patients were r and omized to receive rhFSH alone ( group F ; n = 13 ) or rhFSH + rhLH ( group L ; n = 15 ) .  rhFSH was administered according to a step-down protocol ; patients assigned to group L received rhLH at a fixed dose of 75 IU ( 1 ampoule ) throughout the treatment period . RESULTS The total dose of rhFSH , number of growing follicles , and serum concentrations of estradiol ( E2 ) on the day of hCG administration were similar in both treatment groups . However , the percentage of metaphase II oocytes and fertilization rate were significantly higher in group F than in group L. The lower fertilization rates associated with rhLH were also seen in a subgroup of patients from group L who had undergone a previous ART cycle stimulated with FSH only and thus acted as their own controls . However , when in vitro fertilization ( IVF ) and intracytoplasmic sperm injection cycles were considered separately , differences in fertilization rates were statistically significant only for oocytes treated by conventional IVF . CONCLUSIONS This study shows that the addition of recombinant LH to recombinant FSH in pituitary-suppressed women undergoing ART does not improve the ovarian response and even may have a negative impact on oocyte maturation and fertilization In reproductive medicine little progress has been achieved regarding the clinical management of patients with a reduced ovarian reserve or poor ovarian response ( POR ) to stimulation with exogenous gonadotropins -a frustrating experience for clinicians as well as patients . Despite the efforts to optimize the definition of this subgroup of patients , the existing POR criteria unfortunately comprise a heterogeneous population and , importantly , do not offer any recommendations for clinical h and ling . Recently , the POSEIDON group ( Patient- Oriented Strategies Encompassing Individualize D Oocyte Number ) proposed a new stratification of assisted reproductive technology ( ART ) in patients with a reduced ovarian reserve or unexpected inappropriate ovarian response to exogenous gonadotropins . In brief , four subgroups have been suggested based on quantitative and qualitative parameters , namely , i. Age and the expected aneuploidy rate ; ii . Ovarian biomarkers ( i.e. antral follicle count [ AFC ] and anti-Müllerian hormone [ AMH ] ) , and iii . Ovarian response - provided a previous stimulation cycle was performed . The new classification introduces a more nuanced picture of the “ low prognosis patient ” in ART , using clinical ly relevant criteria to guide the physician to most optimally manage this group of patients . The POSEIDON group also introduced a new measure for successful ART treatment , namely , the ability to retrieve the number of oocytes needed for the specific patient to obtain at least one euploid embryo for transfer . This feature represents a pragmatic endpoint to clinicians and enables the development of prediction models aim ing to reduce the time-to-pregnancy ( TTP ) . Consequently , the POSEIDON stratification should not be applied for retrospective analyses having live birth rate ( LBR ) as endpoint . Such an approach would fail as the attribution of patients to each Poseidon group is related to specific requirements and could only be made prospect ively . On the other h and , any prospect i ve approach ( i.e. RCT ) should be performed separately in each specific group The commercial availability of highly purified , s.c . administered urinary follicle stimulating hormone ( FSH ) preparations for ovarian stimulation marked the beginning of a new era in the treatment of infertility . As these new formulations contain essentially no luteinizing hormone ( LH ) , supplemental LH may be needed for optimal folliculogenesis . It was the aim of this pilot study to compare fertilization rates , embryo morphology , implantation rates and pregnancy outcomes prospect ively in two age-matched patient groups : women who received highly purified FSH ( FSH-HP ) ( n = 17 ) , and women who received FSH-HP plus recombinant human LH ( rhLH , n = 14 ) throughout ovarian stimulation . All patients received mid-luteal pituitary down-regulation with s.c . gonadotrophin-releasing hormone agonist ( GnRHa ) ( leuprolide ) .  Mean implantation rates were 26.9 and 11.9 % in the FSH-HP only and FSH-HP + rhLH groups respectively . The mean clinical pregnancy/initiated cycle rate was 64.7 and 35.7 % for the FSH-HP only and FSH-HP + rhLH patients respectively . FSH-HP patients and FSH-HP + rhLH patients achieved clinical pregnancy/transfer rates of 68.8 and 45.5 % respectively . One patient in the FSH-HP + rhLH group had a spontaneous abortion ; no pregnancy losses occurred in the FSH-HP only group . There were more cancellations for poor ovarian response among FSH-HP + rhLH patients ( n = 3 ) than among FSH-HP patients ( n = 1 ) . The trend toward better pregnancy outcomes among patients who received FSH-HP without supplemental rhLH did not reach statistical significance . It is postulated that appropriate endogenous LH concentrations exist despite luteal GnRHa pituitary suppression , thereby obviating the need for supplemental LH administration PURPOSE The aim of this study was to assess the use of recombinant luteinizing hormone ( rLH ) supplementation in patients who experience a reduction in LH concentration during controlled ovarian hyperstimulation ( COH ) for IVF/ICSI . METHODS A multi-center prospect i ve r and omized controlled trial ( RCT ) was performed over three years . Two hundred and forty patients aged between 24 and 42 years undergoing IVF/ICSI treatment with a long down regulation ( LDR ) protocol were recruited .  LH was measured on the day FSH was started and again 6days later . 100 patients had a 50 % or greater reduction in LH levels  and these were r and omized to receive either recombinant LH ( rLH ) supplementation ( group 1 , n=43 ) or no additional rLH supplementation ( group 2 , n=57 ) . Group 1 received rLH 75IU daily from day 7 of FSH stimulation to the day of HCG trigger . RESULTS There were no differences in either live birth or clinical pregnancy rates per embryo transfer between the two groups ( 27.8 % vs. 37.0 % , p=0.39 , RR=0.75 , 95%CI 0.39 - 1.44 and 36.1 % vs. 43.5 % p=0.51 , RR=0.84 , 95%CI 0.5 - 1.48 , respectively ) . CONCLUSION In conclusion the addition of rLH in patients with a relative reduction in serum LH concentration during COH for IVF/ICSI did not improve live birth or clinical pregnancy rates . However the results were not conclusive and further large well- design ed RCTs are required to confirm these findings Abstract STUDY QUESTION How does the efficacy and safety of a fixed-ratio combination of recombinant human FSH plus recombinant human LH ( follitropin alfa plus lutropin alfa ; r-hFSH/r-hLH ) compare with that of r-hFSH monotherapy for controlled ovarian stimulation ( COS ) in patients with poor ovarian response ( POR ) ? SUMMARY ANSWER The primary and secondary efficacy endpoints were comparable between treatment groups and the safety profile of both treatment regimens was favourable . WHAT IS KNOWN ALREADY Although meta-analyses of clinical trials have suggested some beneficial effect on reproductive outcomes with r-hLH supplementation in patients with POR , the definitions of POR were heterogeneous and limit the comparability across studies . STUDY DESIGN , SIZE , DURATION Phase III , single-blind , active-comparator , r and omized , parallel-group clinical trial . Patients were followed for a single ART cycle . A total of 939 women were r and omized ( 1:1 ) to receive either r-hFSH/r-hLH or r-hFSH . R and omization , stratified by study site and participant age , was conducted via an interactive voice response system . PARTICIPANTS / MATERIAL S , SETTING , METHODS Women classified as having POR , based on criteria incorporating the ESHRE Bologna criteria , were down-regulated with a long GnRH agonist protocol and following successful down-regulation were r and omized ( 1:1 ) to COS with r-hFSH/r-hLH or r-hFSH alone . The primary efficacy endpoint was the number of oocytes retrieved following COS . Safety endpoints included the incidence of adverse events , including ovarian hyperstimulation syndrome ( OHSS ) . Post hoc analyses investigated safety outcomes and correlations between live birth and baseline characteristics ( age and number of oocytes retrieved in previous ART treatment cycles or serum anti-Müllerian hormone ( AMH ) ) . The significance of the treatment effect was tested by generalized linear models ( Poisson regression for counts and logistic regression for binary endpoints ) adjusting for age and country . MAIN RESULTS AND THE ROLE OF CHANCE Of 949 subjects achieving down-regulation , 939 were r and omized to r-hFSH/r-hLH ( n = 477 ) or r-hFSH ( n = 462 ) and received treatment . Efficacy assessment : In the intention-to-treat ( ITT ) population , the mean ( SD ) number of oocytes retrieved ( primary endpoint ) was 3.3 ( 2.71 ) in the r-hFSH/r-hLH group compared with 3.6 ( 2.82 ) in the r-hFSH group ( between-group difference not statistically significant ) . The observed difference between treatment groups ( r-hFSH/r-hLH and r-hFSH , respectively ) for efficacy outcomes decreased over the course of pregnancy ( biochemical pregnancy rate : 17.3 % versus 23.9 % ; clinical pregnancy rate : 14.1 % versus 16.8 % ; ongoing pregnancy rate : 11.0 % versus 12.4 % ; and live birth rate : 10.6 % versus 11.7 % ) . An interaction ( identified post hoc ) between baseline characteristics related to POR and treatment effect was noted for live birth , with r-hFSH/r-hLH associated with a higher live birth rate for patients with moderate or severe POR , whereas r-hFSH was associated with a higher live birth rate for those with mild POR . A post hoc logistic regression analysis indicated that the incidence of total pregnancy outcome failure was lower in the r-hFSH/r-hLH group ( 6.7 % ) compared with the r-hFSH group ( 12.4 % ) with an odds ratio of 0.52 ( 95 % CI 0.33 , 0.82 ; P = 0.005 ) . Safety assessment : The overall proportion of patients with treatment-emergent adverse events ( TEAEs ) occurring during or after r-hFSH/r-hLH or r-hFSH use ( stimulation or post-stimulation phase ) was 19.9 % and 26.8 % , respectively . There was no consistent pattern of TEAEs associated with either treatment . LIMITATIONS , REASONS FOR CAUTION Despite using inclusion criteria for POR incorporating the ESHRE Bologna criteria , further investigation is needed to determine the impact of the heterogeneity of POR in the Bologna patient population . The observed correlation between baseline clinical characteristics related to POR and live birth rate , as well as the observed differences between groups regarding total pregnancy outcome failure were from post hoc analyses , and the study was not powered for these endpoints . In addition , the attrition rate for pregnancy outcomes in this trial may not reflect general medical practice . Furthermore , as the patient population was predominantly White these results might not be applicable to other ethnicities . WIDER IMPLICATION S OF THE FINDINGS In the population of women with POR investigated in this study , although the number of oocytes retrieved was similar following stimulation with either a fixed-ratio combination of r-hFSH/r-hLH or r-hFSH monotherapy , post hoc analyses showed that there was a lower rate of total pregnancy outcome failure in patients receiving r-hFSH/r-hLH  , in addition to a higher live birth rate in patients with moderate and severe POR . These findings are clinical ly relevant and require additional investigation . The benefit : risk balance of treatment with either r-hFSH/r-hLH or r-hFSH remains positive . STUDY FUNDING /COMPETING INTEREST(S ) This study was funded by Merck KGaA , Darmstadt , Germany . P.H. has received honoraria for lectures and unrestricted research grants from Ferring , Merck KGaA and MSD . D.R. is a former employee of EMD Serono , a business of Merck KGaA , Darmstadt , Germany . J.S. , J.H. and W.C. are employees of EMD Serono Research and Development Institute , a business of Merck KGaA , Darmstadt , Germany . T.D.’H. and S.L. are employees of Merck KGaA , Darmstadt , Germany . TRIAL REGISTRATION NUMBER Clinical Trials.gov identifier : NCT02047227 ; EudraCT Number : 2013 - 003817 - 16 . TRIAL REGISTRATION DATE Clinical Trials. 
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Conclusion In conclusion , our analysis confirms that women with a hypo-response to exogenous gonadotropins might benefit from LH supplementation .